18-BI-1206-03: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody CD32b (FcƴRIIB) in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: BioInvent International AB
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if a medicine not yet approved by the FDA, named BI-1206, will help in the treatment of advanced solid tumors and also how safe it is for people to use in combination with pembrolizumab, which is an approved drug under the trade name of Keytruda.
There are 2 parts to this study: Part 1 (dose escalation) Part 2 (dose expansion). When enrollment is completed to Part 1 then Part 2 (dose expansion) will open.
Inclusion Criteria:
– At least 18 years of age on day of signing informed consent.
– Has a histologically confirmed advanced solid tumor.
– Must have received at least 2 doses of an approved anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
– Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
– Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206 (on non-previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor-directed therapy.
– Has an ECOG performance status of 0-1.
– Has adequate organ function as confirmed by laboratory values.
– Has a life expectancy of at least 12 weeks.
Exclusion Criteria:
– Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
– Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable.
– Has cardiac or renal amyloid light-chain amyloidosis.
– Has received chemotherapy or small molecule products within 4 weeks of first dose of BI-1206.
– Has received radiotherapy within 2 weeks of first dose of BI-1206.
– Has received immunotherapy within 4 weeks prior to the first dose of BI-1206.
– Has an active, known or suspected autoimmune disease.
– Has had an allogenic tissue/solid organ transplant.
– Has uncontrolled or significant cardiovascular disease.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Turning Point Therapeutics
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 2
Purpose of study: This is an investigational study of a drug named Reprotrectinib that will be given to patients with advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements. Repotrectinib will provide opportunities in clinic to stop the abnormal cell signaling of ALK/ROS1/TRKs in solid malignancies, and overcome your body’s natural resistance to treatment of advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements.
Inclusion Criteria:
-18 years of age or older
-Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
-At least 1 measurable lesion according to RECIST (v1.1)
-Prior cytotoxic chemotherapy is allowed. At least 14 days must have elapsed after discontinuation of prior cytotoxic chemotherapy before starting study drug.
-Prior immunotherapy (eg, anti-PD-1, anti-PD-L1, anti-TIM3, and anti-OX40) is allowed
-Subjects with advanced solid tumors harboring ALK, ROS1, NTRK1, NTRK2, or NTRK3 rearrangements are eligible. There is no limit to the number of prior chemotherapy, immunotherapy, or TKI regimens.
Exclusion Criteria:
-Concurrent participation in another therapeutic clinical trial.
-Symptomatic brain metastases or leptomeningeal involvement.
-History of previous cancer requiring therapy within the previous 2 years except for squamous cell or basal-cell carcinoma of the skin.
-Major surgery within 4 weeks of start of Reprotrectinib treatment. Radiation therapy within 2 weeks of study entry.
-Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment).
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Principal Investigator: Daniel Anderson, MD
Study sponsor: Merck Sharpe and Dohme Corp.
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 3
Purpose of study: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Inclusion Criteria:
- Has histologically confirmed diagnosis of RCC with clear cell component
- Has received no prior systemic therapy for advanced ccRCC
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
- Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has had major surgery, other than nephrectomy plus resection of preexisting metastases, within 4 weeks prior to randomization
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
- Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
- Has clinically significant cardiac disease within 12 months from first dose of study intervention
- Has a history of interstitial lung disease
- Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
- Has preexisting gastrointestinal or non-gastrointestinal fistula
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B
- Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
- Has clinically significant history of bleeding within 3 months prior to randomization
- Has had an allogenic tissue/solid organ transplant
Study Contact:
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (STELLAR-001) (STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors)
Principal Investigator: Arkadiusz Dudek, MD, PhD.
Study sponsor: Exelixis
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase I
Purpose of study: This study is looking to determine the highest dose tolerable for the study drug XL092 as a single drug or in combination with either the drugs Avelumab, or Atezolizumab. One of the ways XL092 works is by attempting to block VEGFR2 receptor. VEGFR2 is a receptor that helps new blood vessels form, which gives cancer cells a new way to get nutrients. By blocking this receptor, it starves the cancer cells from getting these nutrients. The study is open to the following cancer types; Renal cell carcioma, breast cancer, prostate cancer, colorectal cancer, and urothelial cancer. A detailed breakdown is provided in the inclusion criteria.
Inclusion Criteria:
– Participant must have either;
Clear cell Renal Cell Carinoma (ccRCC) [Cohort A]
Non-clear cell Renal Cell Carinoma (nccRCC) [Cohorts B, E]
Breast Cancer – ER/PR + and HER-2 negative (Cohorts C, F)
metastatic CRPC (Adenocarcinoma of the prostate) [Cohorts D, G]
Colorectal Carcinoma (CRC) [Cohort H]
Urothelial Carcinoma (UC- maintenance therapy) [Cohort I]
Urothelial Carcinoma – Immune Checkpoint inhibitor refractory [Cohort J]
Urothelial Carcinoma – Platinum refractory [Cohort K]
– Must have measurable disease
– Must be able to provide archival, or fresh tumor tissue
– ECOG 0-1
– Adequate organ function as determined by screening tests
– Female subjects who are of childbearing potential must not be pregnant at screening, and sexually active participants and their partners must use contraceptive methods.
– Additional criteria may apply and will be discussed with the physician or research team.
Exclusion Criteria:
– Participant must not have had prior treatment with XL092, prior treatment with anti-PD1/L1 checkpoint inhibitor, or prior avelumab therapy.
– must not have received any chemo, hormonal anticancer or other anticancer antibody within 4 weeks before first dose of study treatment.
– Radiation for bone metastasis within 2 weeks, or other radiation therapy within 4 weeks prior to first dose of study drug.
– Known brain mets or cranial epidural disease, unless adequately treated with radiotherapy or surgery and is stable within 4 weeks prior to first dose of study drug.
– significant or recent illness
– pregnant or lactating females
– diagnosis of another malignancy within 2 years before first dose
The following are for the combination cohorts only (XL092+Avelumab, or XL092+ Atezoluzumab):
– immunodeficiency or receiving steroids within 2 weeks prior to first dose of study drug.
– must not have received a live, attenuated vaccine within 30 days prior to first dose.
– must not have an active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
– Additional criteria may apply and will be discussed with the physician or research team.
Study Contact:
Lisa Wahowske
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
ALK4230-001: A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (ARTISTRY-2)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Alkermes, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to assess the safety and identify the recommended dosing of an experimental drug called ALKS 4230 alone or in combination with a drug that has been approved by the FDA called KEYTRUDA® (pembrolizumab). Eligible patients will be those who have a solid tumor that is resistant to some or all of the available standard treatments, or for which no standard treatment is available.
Inclusion Criteria:
For Part A the subject has histological or cytological evidence of a solid tumor. For Part B the subject must have 1 of the unspecified adult solid tumor types defined in the protocol.
- Record of programmed cell death ligand 1 protein expression status, or availability of fresh or archival tumor tissue for cellular characterization and PD-L1 status.
- Subjects must have adequate liver function.
- Subjects must have adequate kidney function.
- Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery.
- Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study.
- Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered.
- Subject will agree to follow contraceptive requirements defined in the protocol
- Additional criteria may apply.
Exclusion Criteria:
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
- Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
- Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- Subjects who require pharmacologic doses of steroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
- Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
- The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
Act Fast ExSc 2018-07
Principal Investigator: Dylan Zylla, MD
Study sponsor: Exact Sciences
Location: HealthPartners Frauenshuh Cancer Center
Purpose of study: Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion.
Inclusion Criteria:
-Subject is male or female, 40 years of age or older.
-Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.
-Post-colonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
-Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
-Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
-Less than 7 days between colonoscopy and blood and stool sample collection.
-IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.
-Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monalina.Santaana@parknicollet.com
An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies (A Study of SEA-CD40 Given with Other Drugs in Cancers)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Seagen Inc., Merck Sharp & Dohme Corp.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 11
Purpose of study: The purpose of the study is to see if the experimental drug Sea-CD40 given in combination with pembrolizumab works to treat Melanoma and non-small cell lung cancer (NSCLC). Additionally, the study is also looking to see if giving Sea-CD40 in combination with the drugs pembrolizumab, pemetrexed, and carboplatin, works to treat NSCLC. Sea-CD40 works by finding cancer cells and sticking to them, and also sticking to some of the cells that are part of your body’s natural immune system. In doing so, it can help your body identify and help kill off the cancer cells.
Inclusion Criteria:
– Cohort 1: Relapsed/refractory metastatic melanoma; must have progressed on treatment with an anti-PD-(L)1 mAb. Progressive disease must have occurred within 12 weeks from the last dose of anti-PD-L1 mAb.
– Cohort 2: Uveal Melanoma; must not have received prior treatment for advanced or metastatic disease except for adjuvant/neoadjuvant immunotherapy. Also must not have had any regional/liver-directed therapy.
– Cohort 3: Metastatic PD-L1 Naive Melanoma; must not have received prior treatment for metastatic disease except for adjuvant or neoadjuvant immunotherapy. Participants with BRAF/MEK targeted therapy are allowed if they completed therapy at least 4 weeks prior to the first dose of study treatment.
– Cohort 4 and 5: Non-squamous Non-small cell lung cancer; Must have stage 4 disease. Must have non-squamous histology and no prior therapy for metastatic disease. Additionally, must not have any known driver mutations or alteration mutations for which there are already targeted treatments available.
– Additional criteria may apply and can be discussed with the physician or research team.
Exclusion Criteria:
– History of another malignancy within 3 years of first dose of study drug
– Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
– Previous exposure to CD40-targeted therapy
– Currently on chronic systemic steroids in excess of physiologic replacement
– Has had an allogeneic tissue/solid organ transplant.
– History of autoimmune disease that has required systemic treatment in the past 2 years
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Connect Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene Corporation
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of Study: There are three main purposes of this study: (1) To use the information collected to better understand patterns of diagnosis, treatment and outcomes, including disease progression and survival, in patients with MDS and AML; (2) To use the information to better understand patterns of quality of life in patients newly diagnosed with lower-risk MDS, higher-risk MDS, ICUS [Idiopathic Cytopenia of Undetermined Significance] or AML; and (3) To use the results of this study to provide information to better understand the effects of different treatments on a patient’s disease and quality of life. This study does not involve any treatment. Any current treatment will not be affected by participation in this registry study.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monaline.Santaana@ParkNicollet.com
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Purpose of Study: This is an observational (non-interventional) study, meaning there is no drug or treatment being provided as part of the study. As the patient, you will receive standard of care and routine clinical practice, with the purpose of the study being to capture patient characteristics, practice patterns, and different treatment strategies when treating the following types of lymphoma; Relapsed/refractory (R/R), diffuse large B-cell lymphoma (DLBCL), R/R Follicular lymphoma (FL), and primary mediastinal b-cell lymphoma (PMBCL). Additionally, patient-reported health-related quality of life (HRQoL) outcomes will be collected from patients.
Inclusion Criteria:
- Must be ≥18 years of age at the time of consent
- Must have 1 of the following histologically confirmed Non-Hodgkin Lymphoma (NHL) subtypes: Diffuse Large B-cell lymphoma (DLBCL), NOS; or DLBCL High-grade lymphoma, NOS, or DLBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
(Epstien-Barr virus-positive or composite DLBCL are allowed)
Follicular lymphoma (FL)
Primary mediastinal B-cell lymphoma (PMBCL) - Must have been previously treated with at least 1 or more prior systemic therapy (i.e. chemotherapy, immunotherapy, chemoimmunotherapy)
- For first relapsed/refractory (R/R) DLBCL, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have started 3L systemic treatment within 60 days prior to enrolling.
- For second R/R DLBCL cohort, participant must have confirmed second R/R disease or after 2L systemic treatment and must have started 3L treatment within 60 days of enrollment
- For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- For first R/R PMBCL cohort, participant must have confirmed first R/R disease during or after 1L systemic treatment and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- Participant must be willing and able to complete enrollment and follow-up health-related quality of life (HRQoL) and social support instruments
- Participants volunteering for the Tissue Sub-Study must consent for use of their blood/tumor biopsies, which were collected as per standard of care, for exploratory analyses.
- These criteria can further be discussed with the physician or study team.
Exclusion Criteria:
- Participant whose prior start and end date of DLBCL, FL, or PMBCL treatment, and prior treatment received, including chemotherapy, radiation, surgery (not including excisional biopsies), and other anticancer therapy, are unknown
- Participant who has any other active malignancy (non-DLBCL, non-PMBCL, or non-FL) for which the participant is receiving treatment at the time of enrollment or any other former malignancy that was diagnosed within 6 months prior to Registry enrollment (with the exception of non-melanoma skin cancer)
- Currently enrolled in any interventional clinical trial where the participant is being treated with an investigational product that cannot be identified.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monalina.Santaana@parknicollet.com
DF6002-001: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Dragonfly Therapeutics, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of this study is to test the levels of the investigational medicine, DF6002, in your blood, the safety of DF6002, and how people with solid tumor cancers respond to the investigational medicine both by itself as well as in combination with Keytruda (pembrolizumab).
DF6002 is a type of protein that binds to immune receptors which produce an immune response. It is not approved by the FDA. Keytruda is already approved for the treatment of multiple types of solid tumors, but the Sponsor is interested in understanding how the study drug investigational medicine works when given together with Keytruda.
Inclusion Criteria:
– At least 18 yeas of age.
– Histologically or cytologically proven locally advanced or metastatic solid tumors for which no standard therapy exists, or standard therapy has failed.
– ECOG performance status of 0-1.
– Clinical or radiological evidence of disease.
– Adequate hematological, hepatic, and renal function.
– Other criteria may apply depending on tumor type.
Exclusion Criteria:
– Concurrent treatment with a non-permitted drug.
– Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety.
– Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment.
– Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ.
– Rapidly progressive disease.
– Active or history of central nervous system (CNS) metastases.
– Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Destiny 07: A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07)
Principal Investigator: Priya Kumar, MD
Study Sponsor: AstraZeneca, Daiichi Sankyo
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1b/2
Purpose of study: DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer. The study will assign patients to different treatment combinations.
Inclusion Criteria:
- Patients must be at least 18 years of age
- Pathologically documented breast cancer that:
- Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
- Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
- Part 1
- Disease progression on or after the last systemic therapy prior to starting study treatment
- At least 1 prior treatment line in metastatic setting required.
- Part 2 (Modules 0 – 5)
- a) No prior lines of therapy for advanced/MBC allowed
- Part 2 (Module 6 and 7)
- a) Zero or one prior lines of therapy for advanced/MBC allowed
- CNS Inclusion:
- Modules 0 – 5 Patients must have no brain metastases or stable brain metastases.
- Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
- Has a life expectancy of at least 12 weeks.
- Additional criteria may apply and will be discussed with the physician.
Exclusion Criteria:
- Uncontrolled or significant cardiovascular disease
- Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Spinal cord compression or a history of leptomeningeal carcinomatosis
- Prior treatment with immune checkpoint inhibitors
- Prior treatment with an ADC containing a topoisomerase I inhibitor
- Prior treatment with tucatinib
- CNS Exclusion:
- Modules 0 – 5: Has untreated brain metastasis
- Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy
- Additional criteria may apply and will be discussed with the physician.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
Destiny 08: A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (DB-08)
Principal Investigator: Priya Kumar, MD
Study Sponsor: AstraZeneca
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 1
Purpose of study: The study will initially consist of 5 treatment modules, each of which includes Trastuzumab Deruxtecan in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria.
Inclusion Criteria:
- Patients must be at least 18 years of age
- Male or female patients who have pathologically documented breast cancer that:
- Has a history of HER2-low expression; defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay
- Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) or ER and PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
- For patients with HR+ disease:
- Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required.
- Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3.
- For patients with HR- disease:
- Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5.
- Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5.
- Additional criteria may apply and will be discussed with the Physician.
Exclusion Criteria:
- Uncontrolled intercurrent illness
- Uncontrolled or significant cardiovascular disease
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected
- ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses
- Has spinal cord compression or clinically active central nervous system metastases
- Active primary immunodeficiency
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor
- Additional criteria may apply and will be discussed with the Physician.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
EPIK-B3: A Phase III, multicenter, randomized, double blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation (Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3))
Principal Investigator: Dylan Zylla, MD
Study sponsor: Novartis
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel (Abraxene) is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2).
Inclusion Criteria:
– Participant is ≥ 18 years old at the time of informed consent
– Participant has confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC and meets the following criteria;
a. HER2 negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0 or 1+, and
b. ER and PR expression is <1 percent as determined by IHC
– Participant has either:
a. Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR
b. If no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by Computerized Tomography (CT) /Magnetic Resonance Imaging (MRI)) must be present. Subjects with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation.
– Participant has adequate tumor tissue for analysis of PIK3CA mutation and PTEN loss status by a Novartis designated lab. A formalin embedded (FFPE) tumor block from a new OR archival biopsy OR unstained FFPE glass slides must be provided. If archival tumor sample is not available, then a new or recent biopsy is required;
a. if PIK3CA mutation is detected, then subject may be eligible for Part A, if all other criteria met
b. If PTEN loss w/out PIK3CA mutation detected, then patient may be eligible for Part B1 or B2 if all other criteria are met
c. If PTEN loss detected, and PIK3CA status is unknown, then participant may be eligible for Part B1 if all other criteria is met
– Participant has ECOG status of 0 – 1.
– Participant has received no more than one line of therapy for metastatic disease.(Participants with de novo metastatic disease are eligible.)
a. Participant may have received prior taxane-based chemotherapy in the neoadjuvant or adjuvant setting, provided that it has been completed at least 12 months prior to Day 1 of Cycle 1.
b. Participant may have received prior taxane-based chemotherapy for metastatic disease as long as best response has not been progressive disease, and has been completed at least 12 months prior to Day 1 of Cycle 1.
– Participant has adequate bone marrow and organ function based on appropriate lab values
**These inclusion criteria will be discussed in further detail with the provider
Exclusion Criteria:
Participant with the following;
– received prior treatment with any PI3K, mTOR, or AKT Inhibitor
– has known hypersensitivity to Alpelisib, nab-paclitaxel, or any of their excipients
– Participant with inflammatory breast cancer at screening.
– concurrently using other anti-cancer therapy.
– has not recovered from all toxicities related to prior anti-cancer therapies back to a grade 1 based on NCI CTCAE guidelines. (Exception to this criteria is: patients with any grade alopecia are allowed to enter study)
– with Child Pugh score B or C.
– has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
– has a concurrent malignancy or malignancy within 3 years prior to start of study treatment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
– has central nervous system that was not previously treated or newly detected at screening
– has established diagnosis of Diabetes Mellitus type 1 or uncontrolled type 2.
– has impaired GI function or GI disease that may affect the absorption of study drug.
– has history of pancreatitis within 1 year
– concurrent severe or uncontrolled medical condition that would contraindicate the patient’s participation in the study (in the investigator’s judgement)
– currently documented pneumonitis/interstitial lung disease
– clinically significant heart disease or recent cardiac events, including the following; history of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, myocardial infarct within 6 months prior to start of study treatment, documented congestive heart failure (CHF), LVEF <50% at screening as determined by MUGA or ECHO, clinically significant cardiac arrhythmia, Long QT or family history of Long QT or Fridericia’s QTcF > 470ms at screening, Uncontrolled hypertension.
– has history of cutaneous reactions
– unresolved osteonecrosis of the jaw
– participant is receiving CYP3A3 or BCRP inhibitors and cannot discontinue 7 days prior to initiating study treatment
– currently receiving systemic corticosteroids within 2 weeks of starting study drug.
– has had prior investigational drug within 30 days prior to study start
– if participant is unable to understand or comply w/ study instructions or requirements
– participant is woman of child-bearing potential that is capable of becoming pregnant unles using highly effective contraception during study treatment and for 6 months after last dose.
– Sexually active male unwilling to use contraceptives during intercourse and for 6 months after last dose
– is a nursing (lactating) or pregnant woman as confirmed by positive serum (hCG) test prior to starting study treatment
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
EVOKE-01: Sacituzumab Govatican vs. Docetaxel in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with progression after Platinum-based chemo or anti-PD-1/PD-L1 immunotherapy.
Principal Investigator: Rachel Lerner, MD
Study sponsor: Gilead Sciences
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of the study is to compare the overall survival in patients taking Sacituzumab Govetican vs. those taking Docetaxel. This is done by looking at how long you are able to stay on one treatment before your disease progresses, as well as what sort of reaction the disease has to the drug (if the tumor gets smaller), and how well you are able to tolerate the side effects of the drug. The drug works by helping to deliver higher concentrations of chemotherapy to the cancer cells and tumor, while trying to avoid damage to normal healthy tissue and organs.
Inclusion Criteria:
– Documented Stage IV NSCLC at time of enrollment
– Progressed on both platinum-based chemo + anti-PD-L1/PD-1 combination or progressed on both sequentially (one after the other).
– Measurable disease via CT/MRI per RECIST 1.1
– ECOG 0-1
– Adequate organ function based on lab results.
– Participants must agree to contraceptives if engaging in sexual activity.
– Additional criteria may apply, and will be discussed with the physician or research team.
Exclusion Criteria:
– Mixed small-cell lung cancer and NSCLC histology.
– Positive serum pregnancy test.
– Received prior anticancer agent within 4 weeks prior to study enrollment, or has received prior chemo, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered from the associated adverse events by the planned study entry time.
– Previously received treatment with any of the following; Topoisomerase 1 inhibitors,Trop-2 targeted therapy, Docetaxel as monotherapy or combination with other agents.
– Has active second malignancy
– has NSCLC that is eligible for local therapy.
– severe pulmonary illness or any underlying pulmonary disorder
– known active central nervous system metastasis or carcinomatous meningitis.
– active cardiac disease.
– Active IBD or GI perforation within 6 months of enrollment.
– has infection requiring antibiotics.
– Positive for HIV or Hepatitis B or Hepatitis C
– Additional exclusion criteria may apply, and will be discussed with the physician or research team.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
GNX-001: A Phase I Study of GNX102 in patients with Advanced Solid Tumors
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Glyconex, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purposes of this study are to determine the right dose of GNX102 that can be tolerated by people with cancer, and, to see if it can shrink the tumors. GNX102, is an antibody that binds to a certain target on the surface of the cancer cells. This target has been shown to be present on the surface of many different types of tumors. When this study medication binds to this target it is thought that it may kill the cancer cells.
Eligible patients will be those that have cancer that has continued to grow despite having tried many different treatments.
Inclusion Criteria:
– Must be at least 18 years of age.
– Must have histologially confimred solid tumor with a likelihood of expression of GNX102 targeted antigens (for example: colorectal, hepatocellular, non-small cell lung, gastric, breast, bladder, pancreatic, melanoma, esophageal, prostate, ovarian, cervical, and epithelial uterine cancers).
– Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit.
– ECOG performance status of 0-1
– Acceptable liver, renal, and hematologic function (as determined by blood tests).
– Acceptable coagulation status.
– Life expectancy of at least 3 months.
– Other criteria may apply.
Exclusion Criteria:
– Has any other malignancy.
– Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test.
– Has New York Heart Association Class III or IV heart disease.
– History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
– History of cerebral vascular accident or transient ischemic attack within the past 6 months.
– History of primary CNS tumor.
– History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment.
– Active, nonmalignant gastrointestinal (GI) disease requiring treatment (such as inflammatory bowel disease, Crohn’s disease, colitis) that would impart excess risk associated with study participation or study drug administration
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
HC-404-FCP-2011: A Multicenter, Open-label, Phase 1a Study of HC 5404-FU in Subjects with Selected, Advanced Solid Tumors.
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: HiberCell, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: This is a first-in-human study designed to establish the maximum tolerated dose, and to evaluate the safety and tolerability of oral drug HC-5404-FU in subjects with advanced solid tumors. Specific tumor types evaluated in this study are; renal cell carcinoma, gastric cancer, metastatic breast cancer, or small-cell lung cancer. HC-5404-FU is highly selective for protein kinase RNA-like endoplasmic reticulum kinase (PERK) and acts as a PERK inhibitor. PERK plays an important role in tumor growth and new blood vessel development, therefore interfering with PERK function could potentially lead to tumor growth inhibition.
Inclusion Criteria:
– Be ≥18 years of age (male or female) at the time of consent
– Have 1 of the following histologically or cytologically confirmed tumor types with qualifying characteristics, and have received a minimum of 3 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease:
a. RCC (renal cell carcinoma – clear cell or papillary)
b. GC (gastric adenocarcinoma)
c. Human epidermal growth factor receptor positive (HER2+) MBC
(metastatic breast cancer)
d. SCLC (small cell lung cancer)
– Have at least 1 radiologically measurable lesion as per RECIST v1.1.
– Two biopsies will be necessary: One at baseline (within 30 days prior to first dose) and one within 7 days after Cycle 3/Day 1.
– ECOG Status of 0 or 1.
– Have life expectancy of 3 months or greater as determined by the treating physician.
– Have adequate organ function within 15 days prior to first dose.
– Be willing and have the ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
– Additional criteria may apply and will be discussed with the physician or research team.
Exclusion Criteria:
– Is currently pregnant, planning to become pregnant, or breastfeeding.
– Has had prior chemo, radiation, or targeted small molecule therapy within 2 weeks or has not recovered from adverse reactions due to previous treatment prior to first dose of study drug.
– Currently participating in clinical trial or has received investigational treatment within the last 4 weeks prior to first dose of HC-5404 study drug.
– Has known active Tuberculosis, HIV, known active Hepatitis B or C, a clinically severe autoimmune disease, or a history of organ transplant. Additionally, must not have diagnosis of immunodeficiency for which subject is receiving systemic steroid therapy or other immunosuppressive therapy.
– Has been diagnosed with Covid-19 at 7 days prior to starting first dose.
– Has insulin dependent Type I diabetes or poorly controlled Type 2 diabetes (per physician discretion).
– Has known active central nervous system metastasis or carcinomatous meningitis. Patients w/ previous brain mets may participate if they are stable for at least 4 weeks, are not using systemic steroids for 7 days, and have no evidence of new or enlarging brain mets. (Carcinomatous Meningitis excluded)
– Has history of lung disease, pneumonitis within 12 months, or current pneumonitis, or has an active infection requiring systemic therapy.
– Has a history or ongoing cardiovascular disease; unstable angina, myocardial infarction, acute coronary syndrome, symptomatic or uncontrolled arrhythmia, CHF, or baseline ECG abnormalities such as prolonged QTc, or any Class III / IV cardiac diseases as defined by NYHA.
– Known psychiatric or substance abuse disorders that would interfere with informed consent or cooperation with requirements of the trial.
– Additional criteria may apply and will be discussed with the physician or research team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
LUN18-357: Induction Durvalumab Followed by Chemoradiation and Consolidation Durvalumab (MEDI4736) for Stage III Non-small Cell Lung Cancer
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: AstraZeneca, Hoosier Cancer Research Network
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 2
Purpose of study: The purpose of the study is to find out if adding durvalumab prior to chemoradiation (induction) will make your cancer respond better than the usual approach. The usual approach is defined as care most people get for stage 3 non-small cell lung cancer.
Inclusion Criteria:
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1.
- Histological or cytological confirmation of stage III non-small cell lung cancer, eligible for curative-intent concurrent chemoradiation. NOTE: subjects are not candidates for surgical resection either due to medical inoperability or surgically unresectable disease
- Measurable disease according to RECIST 1.1 criteria.
- Plan for treatment with concurrent chemoradiation with a dose of radiation ranging from 54-66 Gy
- Have adequate organ function as determined by standard blood tests.
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.
- Life expectancy of at least 12 weeks per investigator discretion.
- Other criteria may apply.
Exclusion Criteria:
- Prior therapy for stage III NSCLC. Mixed histology with small cell lung cancer will not be allowed.
- Sequential chemoradiation will not be permitted.
- Induction and consolidation chemotherapy (separate from concurrent chemoradiation) will not be allowed.
- Prior exposure to anti-PD-1 or anti-PD-L1 antibodies including durvalumab.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. Some exceptions apply.
- History of pulmonary fibrosis, interstitial lung disease, or pneumonitis requiring steroids.
- Active or prior documented autoimmune disease within the last 2 years. Patients with vitiligo, stable hypothyroidism, Grave’s disease, or psoriasis not requiring systemic treatment are not excluded.
- Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.
- Active other malignancy; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer.
- History of organ transplantation (including allogeneic stem cell transplantation).
- Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
Mayo Clinic MC17C1
Principal Investigator: Dylan Zylla, MD
Study sponsor: Mayo Clinic
Locations:
-HealthPartners Frauenshuh Cancer Center
-HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
Inclusion Criteria:
-Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted).
-Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart? 14 days of registration and continue for at least 28 days.
-Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided).
-Patient must complete baseline quality of life (QOL) packet.
Exclusion Criteria:
-Patient has a prior allergy or intolerance of ketoconazole.
-Patient has an allergy or intolerance to sulfites.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monaline.Santaana@parknicollet.com
NP303-102; ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating Crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors receiving targeted-cancer therapies with or without standard chemotherapy regimens
Principal Investigator: Dylan Zylla, MD
Study sponsor: Napo Pharmaceuticals
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: This is a Phase 3 randomized, double-blind placebo-controlled trial looking to evaluate safety and efficacy of prophylactic use of Crofelemer for diarrhea in adult patients with solid tumors. Participants are randomized 1:1 ratio to either crofelemer arm (experimental), or placebo arm. This study is not treating the cancer specifically, but instead is looking at managing diarrhea as a side effect from some of the anti-cancer treatments available.
Inclusion Criteria:
– Patients to receive targeted cancer therapy drugs that have diarrhea incidence of 50% (tyosine kynase inhibitors,CDK inhibitors, anti-EGFRs) for treatment of solid tumors.
– Patient able to provide informed consent.
– Men and Women >/= to 18 years of age.
– Pathologically or radiologically confirmed diagnosis of solid tumors scheduled to receive targeted cancer therapy.
– Patient must be eligible to receive targeted cancer therapy with or without cycle chemotherapy.
– Must have an ECOG of 0-2.
– Must have negative urine pregnancy test at time of consent for women of child-bearing potential.
Exclusion Criteria:
– Receiving any type of immunotherapy
– Any cancer therapy where antidiarrheal medications are mandatory
– Ongoing irritable bowel syndrome or colitis
– Ongoing diarrhea or diarrheal episodes within 7 days prior to randomization to study arm.
– Laxative use within 7 days prior to randomization, or history of constipation that required use of laxatives for more than at least 30 days.
– Inadequate organ function based on lab results
– Use of other investigational drugs within 4 weeks of signed informed consent.
– Use of antibiotics within past 7 days prior to randomization.
– Total colectomy and/or any type of gastrointestinal ostomy
– Major abdominal or pelvic surgery within 3 months, or any previous (within 1 month) or planned abdominal or pelvic radiation
– Active systemic infection requiring ongoing intervention, including oral and IV antibiotics, anti-fungal, anti-parasitic, and anti-viral drugs.
– Inability to comply with study requirements
– Pregnant and/or breastfeeding.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma – ARTISTRY-6 (ARTISTRY-6)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Alkermes
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 2
Purpose of study: This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
Inclusion Criteria:
- The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2).
- Patient must have received previous treatment as follows: a) patient has received anti-PD-[L]1 therapy ± anti-CTLA-4 therapy, and ≤1 other prior regimen of systemic anti-neoplastic therapy; b) patient should have experienced objective response (PR or CR) or SD as BOR to anti-PD-[L]1 therapy; c) patients with BRAF mutations may or may not have received prior targeted therapy.
- Patients must have disease that is measurable based on RECIST 1.1., that has not recently been irradiated or used to collect a biopsy.
- Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue.
- Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months.
- Additional criteria may apply.
Exclusion Criteria:
- Patient has uveal melanoma.
- Patient has received prior IL-2-based or IL-15-based cytokine therapy.
- Patient requires systemic corticosteroids (>10 mg of prednisone daily, or equivalent) however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
- Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.
- Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to begin breastfeeding during the study period or within 30 days after last study drug administration.
- Patients with active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy and/or gamma knife, the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less of corticosteroids for at least 2 weeks before the first dose, and the subject is neurologically stable. Patients with leptomeningeal disease are excluded.
- Patient has known or suspected hypersensitivity to any components of nemvaleukin.
- Patients with an uncontrollable bleeding disorder.
- Patient has QT interval corrected by the Fridericia Correction Formula values of >470 msec (in females) or >450 msec (in males); patient who is known to have congenital prolonged QT syndromes; or patient who is on medications known to cause prolonged QT interval on ECG.
- Patient has developed Grade ≥3 immune-related AEs (irAEs) while on prior immunotherapy, (eg, pneumonitis, nephritis, and neuropathy).
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2)
Principal Investigator: Rachel Lerner, MD
Study sponsor: AstraZeneca
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: This phase 2 randomized 1:1 study is split into 2 arms. Patients will either receive (Arm 1) Durvalumab + Chemotherapy + Oleclumab (before surgery) followed by Durvalumab + Oleclumab after surgery, OR (Arm 2) Durvalumab + Chemotherapy + Monalizumab (Before surgery) and Durvalumab + Monalizumab after surgery. The purpose of the study is to determine the safety and tolerability of the treatments.
Durvalumab is a type of anti-cancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune
system can then attack and kill the cancer cells.
Oleclumab is an antibody, a natural protein made by your immune system that binds to a molecule called CD73. The normal function of CD73 is to produce another molecule named adenosine. When too much adenosine is produced it can reduce the ability of the immune system to function. Oleclumab works by reducing CD73’s ability to produce adenosine, therefore helping the immune system to function, and potentially prevent cancer growth.
Monalizumab is also an antibody and binds to a molecule called CD94/NKG2a. The normal function of this molecule is to limit the action of the body’s natural killer cells (which are a type of immune cell) against tumor cells. When monalizumab binds to CD94/NKG2, it blocks the molecule’s ability to function. This helps the immune system to function better by allowing more of the body’s natural killer cells to be available to kill the cancer cells.
Inclusion Criteria:
– Newly diagnosed NSCLC with Resectable disease (Stage IIA to IIIA)
– ECOG 0-1
– Adequate organ function
– Must be able to provide tumor sample for confirmation of PD-L1 status, EGFR, or ALK status.
– Pre- or Post-bronchodilator forced expiratory volume in 1 (FEV1) of 1.0L and diffusing lung capacity for carbon monoxide (DLCO) > 40% post-op predicted value.
Exclusion Criteria:
– Patients with EGFR mutations or ALK Translocations
– History of allogeneic organ transplantation
– Active or prior autoimmune or inflammatory disorders
– Uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, chronic gastrointestinal conditions associated w/ diarrhea
– Psychiatric illness or social situations that would limit patient’s ability to comply with study requirements.
– history of another primary malignancy or has small-cell or mixed small-cell lung cancer
– has moderate or severe cardiovascular disease
– prior exposure to immune-mediated therapy. Patients receiving agents targeting adenosine pathway and anti-NKG2A agents are also excluded.
– Current or prior use of immunosuppressive meds within 14 days prior to first dose of study drug.
– Additional exclusion criteria may apply as well, and will be discussed with the physician or study team.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
PGG-BCA2121: A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Patients with Metastatic Breast Cancer (mBCA) Who Have Progressed Through Prior Hormonal Therapy
Principal Investigator: Rachel Lerner, MD
Study Sponsor: HiberCell, Inc., Merck Sharp & Dohme Corp.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: The main purpose of the study is to determine overall response rate following treatment with the study drug Imprime PGG in combination with Pembrolizumab (Keytruda) in patients with metastatic breast cancer. Imprime PGG acts as a PAMP or Pathogen-Associated Molecular Pattern, and it works by activating the innate immune response of the body’s immune system to help the body better recognize and attack cancer cells. Once the cancer cells are recognized by the body, Imprime PGG also works to help activate the immune system’s cell killing functions to help target and destroy the cancer cells.
Inclusion Criteria:
– Must be 18 years or older
– Must have confirmed diagnosis of ER/PR+/HER-2 (-) breast cancer subtype:
a. HR+: Positive for estrogen receptor and/or progesterone receptor staining
b. HER2- : Immunohistochemistry assay demonstrating no or faint staining in < or =10% of tumor cells
– IgG anti-β-glucan antibody (ABA) of greater than, or equal to 20 mcg/mL
– Must have progressed on one hormone therapy + CDK4/6 inhibitor, and up to two lines of prior chemotherapy.
– Be able to provide archival tissue and undergo an on-treatment biopsy of a previously not radiated lesion
– ECOG performance status of 0-1
– Negative COVID test at screening
-Adequate organ function, and women of childbearing potential (WOCBP) must have negative pregnancy test within 72hrs prior to first dose
Additional criteria may apply and will be discussed with the physician/research team.
Exclusion Criteria:
– Has received prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
– Received prior radiotherapy within 2 weeks of starting study treatment.
– Received prior systemic anti-cancer therapy and investigational agents within 4 weeks to study day 1.
– Is currently participating in a study of an investigational drug or used an investigational device within 4 weeks of starting study treatment.
– Was previously exposed to Imprime (study drug)
– Has hypersensitivity to Pembrolizumab (Grade 3 or higher)
– Has received a live or attenuated vaccine within 30 days prior to first study dose.
– Had an allogenic tissue/solid organ transplant
– Has known active brain metastasis (patient can participate if brain mets are radiologically stable)
– Has known history of HIV, Hepatitis B, or Hepatitis C infection.
– Has clinically significant cardiovascular disease
– Known substance abuse disorder that would impact patient’s ability to cooperate with study schedule.
Other exclusion criteria may apply and will be discussed with physician/research team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.gavenda@parknicollet.com
RGX-104-001: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies (RGX-104-001)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Rgenix, Inc. , Inc.
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if the experimental drug called RGX-104 used in combination with docetaxel, will help in the treatment of small cell lung cancer (SCLC). We are also testing RGX-104 in combination with pembrolizumab, carboplatin, and pemetrexed in patients with non-small cell lung cancer (NSCLC). We are trying to find the best dose to use that will benefit patients with SCLC or NSCLC.
Inclusion Criteria:
For patients with NSCLC enrolled in the pembrolizumab plus carboplatin/pemetrexed combination dose escalation or expansion stages:
- The patient must have histologic or cytologic evidence of newly-diagnosed non-squamous, NSCLC that is advanced disease, defined as cancer that is either metastatic (Stage 4) or locally advanced (Stage 3B) and unresectable.
- The patient has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
- The patient has not received prior systemic treatment for their advanced/metastatic disease.
- For patients in the expansion stage only: the patient’s tumor block must demonstrate PD-L1 expression TPS <1% as determined with a validated assay.
- The patient must have adequate organ function and performance status eligible for treatment with a platinum-based regimen and checkpoint inhibitor.
For patients with SCLC enrolled in the docetaxel combination expansion stage:
- The patient must have a pathologically confirmed (by histology or cytology) diagnosis of SCLC, which is currently extensive disease (disease outside a single radiation port), or of metastatic neuroendocrine cancer with small cell or high-grade features. Patients with metastatic neuroendocrine cancer with small cell or high-grade features must have a pathology report supplied to the sponsor before treatment.
- The patient must have demonstrated disease progression following platinum-based chemotherapy with or without a PD-1/L1 inhibitor for SCLC, or following a different, acceptable first-line regimen for high-grade neuroendocrine tumors.
- The patient must have received no more than 1 prior line of therapy for extensive disease.
Patients enrolled in the expansion stages must agree to a tumor biopsy to be obtained during the screening period and toward the beginning of Cycle 2 or at the time of PD, if earlier.
Patients must have disease that is measurable.
Patients must be ≥18 years old.
Patients must have a normal left ventricular ejection fraction as measured by an ECHO or MUGA
Additional criteria may apply.
Exclusion Criteria:
- Has persistent clinically significant toxicities (Grade ≥2) from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy and alopecia which are permitted). Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ≤1, unless a higher-grade abnormality is allowed by the inclusion criteria. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
- Has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study therapy administration
- Has received treatment with an investigational systemic anticancer agent within 14 days prior to study therapy administration.
- Has previously received treatment with RGX-104 or another investigational agent that is a known LXR agonist.
- Has clinically significant cardiovascular disease or uncontrolled, clinical significant pulmonary disease.
- Has known active or suspected brain or leptomeningeal metastases.
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
TAK 981-1002: A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019 (COVID-19)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Takeda Pharmaceuticals
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of Study: The purpose of this study is to evaluate safety, tolerability and to identify the most appropriate dose of TAK-981 as treatment for patients with cancer. In addition, this study will also serve to obtain information on the amount of study drug in your blood after taking single and/or multiple doses of the study drug.
The main purposes of this study are:
– To determine if TAK-981 is safe in patients with cancer.
– To select the dose for future studies.
– To measure the amount of TAK-981 in your blood.
– To assess the anti-tumor effect of TAK-981.
– To assess how the research drug reaches its target protein (called SUMO activating enzyme). Small Ubiquitin-like
Modifier (or SUMO) proteins are proteins that attach and detach from other proteins. This happens in normal and
tumor cells to modify their function. SUMOylation is the process of adding these SUMO proteins to other proteins.
The process of SUMOylation allows growth of tumor cells, and prevents the immune system from attacking the
tumor. TAK-981 reduces SUMOylation, allowing the immune system to attack the tumor cells.
– To obtain information on how your body reacts to the study drug by looking at biomarkers. Biomarkers are
measurable substances that can be found in different tissues of your body like the blood, skin and the tumor.
– To determine if the amount of TAK-981 in your blood has any impact on your ECG results (heart function test).
TAK-981 is an investigational drug that has not yet been studied in humans. It has not been approved by the FDA (U.S. Food and Drug Administration) or other regulatory authorities for use by the general public. TAK-981 will be investigated in adult patients with metastatic solid tumors or lymphomas for which standard curative treatment or life-prolonging treatment does not exist, is no longer effective or if it cannot be tolerated or is not indicated for you.
Inclusion Criteria:
– Adult male of female patients >/= 18 years old.
– Eastern Cooperative Group (ECOG) performance status of 0 to 1.
– Patients with histologically confirmed advanced (local regionally recurrent not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them, OR
– Patients with relapsed/refractory lymphoma not amenable to therapies with proven clinical benefit or who are intolerant or who refuse them. Patients with low-grade lymphomas such as follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, and marginal zone lymphomas may not need to exhaust all available therapy.
– Adequate bone marrow reserve and renal and hepatic function.
Exclusion Criteria:
– Treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter. Patients should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia and peripheral neuropathy), or the toxicity is considered established as a sequela.
– History of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and the patients is receiving a corticosteroid dose ≤10 mg/day of prednisone equivalent at the time of receiving the first dose of TAK-981. For asymptomatic patients, screening brain imaging is not required.
– Patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to grade 1 or better from related side effects of such therapy (except for alopecia).
– Patient is receiving any live vaccine (eg, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
– History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
TAK573-1001: An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Modakafusp Alfa (TAK-573) as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors
Principal Investigator: Arkudiusz Dudek, MD, PhD
Study sponsor: Takeda
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: II
Purpose of study: The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity as single drug or in combination with pembrolizumab (Keytruda) in patients with locally advanced or metastatic solid tumors. The study will consist of 2 phases: Phase 1b dose escalation and a Phase 2 dose expansion.
Inclusion Criteria:
– Must be 18 years or older
– Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
– Measurable disease. At least 1 target lesion amenable for biopsy is required for enrollment in Phase 1b, and a minimum of one target lesion for response assessment is required to enroll in phase 2.
– Phase 1b Dose Escalation; Participants with confirmed locally advanced OR metastatic solid tumors.
– Phase 2 Dose Expansion will include the following;
I. Unresectable/metastatic histologically confirmed cutaneous melanoma with primary resistance to no more
than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
II. Unresectable/metastatic histologically confirmed cutaneous melanoma with acquired resistance to no more
than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic histologically confirmed cutaneous melanoma naive to prior anti-PD1 containing
treatments in the metastatic setting.
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- Participants with BRAF V600E mutant melanoma may have received prior BRAF inhibitor
therapy. - For the expansion cohorts I and II, the initiation of treatment in the current study should be within the
12 months of the completion of the last anti-PD1 containing treatment. - For the expansion cohort III, participants who received an anti-PD-1 treatment in the adjuvant setting
must have completed that treatment at least 6 months prior to enrollment and must not have
progressed on the anti-PD1 adjuvant treatment. - Primary resistance is defined as a best response of PD or SD less than (<) 6 months to an anti-PD1
alone or in combination with other agents (that is, CTLA4) in the initial anti-PD1 containing treatment. - Acquired resistance is defined as a progression following a best response of CR, PR or SD>6 months
to a prior anti-PD1 alone or in combination with other agents (that is, CTLA4). - Participant has a concurrent malignancy or malignancy within 3 years prior to start of study treatment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
- Participants with BRAF V600E mutant melanoma may have received prior BRAF inhibitor
– There may be additional criteria and they can be discussed with the physician or research team.
Exclusion Criteria:
– Toxicity/side effects from previous treatments that have not resolved to </= grade 1 per CTCAE 5.0 prior to first dose of TAK-573; excluding Grade 2 neuropathy, asthenia/fatigue, or alopecia.
– History of the following within 6 months prior to first dose; NYHA Grade III or IV, Congestive Heart Failure (CHF), unstable anginia, myocardial infarction, unstable symptomatic ischemic heart disease, any grade 2 or higher ongoing cardiac arrhythmias, other serious cardiac conditions
– Baseline QT interval with Fridericia’s Correction (QTcF) greater than (>) 480 milliseconds, history of long TQ syndrome, or Torsades de Pointes.
– Ongoing active infection
– Known history of HIV or other congenital or acquired immunodeficiency.
– Known Hepatitis B (HBV) or Hepatitis C
– Autoimmune disease requiring immunosuppressive therapy
– Additional criteria may apply and can be discussed in more detail with physician or research team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
TTX-080-001: A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination with Pembrolizumab or Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies (TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Tizona Therapeutics, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I
Purpose of study: The main purpose of the study is to test the effects of the investigational drug TTX-080 as a single therapy, or in combination with either Pembrolizumab, or Cetuximab. TTX-080 is an antibody made in a laboratory and binds to a protein called HLA-G and blocks its suppressive function. Antibodies are naturally made by the body in reaction against foreign substances (such as bacteria and viruses) that get in the body. Cancer cells use HLA-G to suppress the body’s immune system response and help cancer cells grow. By blocking HLA-G, TTX-080 may help your immune system attack cancer cells.
Inclusion Criteria:
-Age 18 years or older, is willing and able to provide informed consent
-Documented locally advanced or metastatic solid tumor
-Evidence of measurable disease by CT scan per RECIST 1.1
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
-Fresh biopsy is mandatory for Phase 1b – Dose Expansion, unless determined by the physician that biopsy is not in patient’s best interests. Archival tissue will need to be collected in place of fresh tissue if unavailable. Fresh biopsy and/or archival tissue is optional for Phase 1a – Dose Escalation.
-Adequate organ and marrow function
-Women of child bearing potential must use contraception through 120 days after the last dose of experimental treatment.
-Additional criteria may apply and will be discussed with the physician or research team
Exclusion Criteria:
-Active brain metastases or leptomeningeal metastases (patients w/ brain mets may be eligible if stable disease for at least 4 weeks after definitive therapy, and have not used steroids for at least 2 weeks prior to first dose of TTX-080).
-History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
-Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
-Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
-History of severe autoimmune disease
-Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
-Additional criteria may apply and will be discussed with the physician or research team
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
The Connect for Cancer Prevention Study
Principal Investigator: Pamala Pawloski, Pharm.D., BCOP, FCCP
Study sponsor: The National Cancer Institute (NCI), part of the National Institutes of Health (NIH)
Location: HealthPartners Neuroscience Center
Purpose of study: The Connect for Cancer Prevention Study will help us better understand the causes of cancer and how to prevent it. HealthPartners is one of nine health care systems throughout the country to partner with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for Connect. The study will include 200,000 adults.
Participants will be asked to answer online health surveys, donate samples of blood, urine, and saliva, and share access to their electronic health records. This information will help researchers study the health and behavior patterns that may affect cancer risk. It takes time to understand the causes of cancer, so Connect will go on for many years. The longer you participate, the more we may learn.
Inclusion Criteria: HealthPartners patients between 40 and 65 years old who have never had cancer. People who have or once had non-melanoma skin cancer, or a condition that raises the risk of getting cancer (such as DCIS, or stage 0 breast cancer), can still join.
Study Contact:
The Connect team at HealthPartners
(952) 967-5067
ConnectStudy@HealthPartners.com
XTX202 in Patients With Advanced Solid Tumors (XTX202-01: A study of XTX202 as single drug in Patients With Advanced Solid Tumors)
Principal Investigator: Arkadiusz Dudek, MD, PhD.
Study sponsor: Xilio Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I/II
Purpose of study: This is a first-in-human study that is looking to test the safety and maximum tolerated dose of experimental drug XTX202 as a single treatment. The study is composed of 2 parts; Phase 1 (dose escalation) that is focused on finding the highest tolerated dose, and Phase 2 – which is split up into Phase 2a (patients with renal cell cancer), and Phase 2b (patients with melanoma). Phase 1 is open to multiple advanced solid tumors.
Inclusion Criteria:
Phase 1:
– Confirmed locally advanced or metastatic solid tumor that failed standard therapy.
Phase 2a:
– Patients with metastatic renal cell carcinoma that have been previously treated with Anti-PD-1 or TKI. They must have progressed on anti-PD-1 mAb as single drug or in combination with other therapies.
Phase2b:
– Unresectable or metastatic melanoma previously treated with Anti-PD-1 or anti-CTLA4 checkpoint inhibitors.
– ECOG of 0-1
– Adequate organ function
Exclusion Criteria:
– Received prior treatment with IL-2 therapy
– History of clinically significant pulmonary disease
– History of clinically significant cardiovascular disease
– Has a diagnosis of immunodeficiency
– Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
– Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1817
Lisa.Wahowske@parknicollet.com
