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: Yan Ji, MD
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 Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults with Hormone Receptor-Positive Breast Cancer (CanAroma)
Principal Investigator: Dylan Zylla, MD
Study sponsor: University of Minnesota
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Pilot
Purpose of study: This is a supportive care/ quality of life study that is looking to examine the feasibility of topical medical cannabis cream as a treatment option for AIMSS (Aromatase Inhibitor-associated Musculoskeletal Syndrome). AIMSS is a common occurrance in breast cancer patients that use Aromatase inhibitors to treat hormone-positive breast cancer. The goal of the study is to compare cannabis cream that has a high concentration of THC, and cannabis cream that has a high concentration of CBD and see how these treatments affect the pain associated with AIMSS.
Inclusion Criteria:
– Must be 18 years or older
– Histologically proven diagnosis of Stage I – III invasive breast cancer
– Currently taking a prescribed dose of Aromatase Inhibitor (such as anastrazole, letrozole, exemestane) for at least 60 days, with plans to continue for at least 4 weeks after the time of consent to this study.
– Must have initiated Aromatase Inhibitor therapy within 36 months at the time of signing consent for this study.
– Experiencing AIMSS in hands and/or wrists for at least 4 weeks prior to time of consent to the study.
– Must report a score of 4 or higher on at least 1 of 4 M-SACRAH questions about pain and stiffness in hands/wrists over the past 7 days. Patients experiencing pain in other joints are eligible, but must have pain in hands/wrists as well.
– Must be willing to be registered with the Minnesota Medical Cannabis Program (MMCP)
– Must meet qualifications for MMCP
a. Must have qualifying condition per MMCP requirements, as certified by a Healthcare practitioner.
b. Must be a Minnesota resident.
Exclusion Criteria:
– Patient is currently using, or has used cannabinoids within 4 weeks of time of consent to study.
– Has active skin lesions on hands/wrists that, in the opinion of the physician, could impair absorption of cannabinoid cream, or lead to increased toxicity such as psoriasis, cellulitis, cutaneous lupus erythematosus, or hand-foot syndrome.
– Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms. Patients are still eligible for the study if they are currently on a stable dose of AIMSS related medication for 4 weeks with no plans to increase the dose.
– Current or planned initiation of acupuncture to arms, wrists or hands within the study period.
– Known hypersensitivity to topical cannabinoids.
– Any condition that, in the physician’s opinion, could interfere with the ability to provide informed consent or would interfere with the patient’s ability to comply with the study protocol.
Study Contact:
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next generation Hormonal Agent (NHA)
Principal Investigator: Dylan Zylla, MD
Study sponsor:Merck Sharpe & Dohme LLC
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to test the safety and effectiveness of the study drug MK-5684 combined with hormone replacement therapy (HRT) compared to alternative Abiraterone acetate or Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
– Have histologically or cytologically confirmed adenocarcinoma of prostate without small cell histology.
– Have current evidence of metastatic disease documented either by bone lesions on bone scan, or by soft tissue disease documented by CT or MRI scan.
– Has prostate cancer progression while receiving androgen deprivation therapy.
– Has had disease progress during or after treatment with one next-generation hormonal agent.
– Has ECOG of 0 – 1.
– Has adequate organ function as determined by lab tests.
– Has provided tumor tissue from fresh core or excisional biopsy from soft tissue that was not previously radiated.
– Participants that test positive for Hepatitis B are eligible if they have received antiviral therapy for at least 4 weeks,and have undetectable load prior to randomization. Additionally, participants with Hepatitis C are eligible if viral load is undetectable at screening.
– HIV positive patients must be on well controlled antiretroviral therapy.
– Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Has other Gastrointestinal condition
– Unable to swallow capsules/tablets
– Has poorly controlled diabetes mellitus
– Has active or unstable cardio/Cerebro-vascular disease or thromboembolic events.
– Has significant abnormal sodium or potassium levels, or hypotension at screening.
– History or family history of long QTc Syndrome.
– Has history of seizures within 6 months prior to signing consent, or condition that may predispose to seizures within 12 months prior to signing consent.
– Has previously received Taxane-based chemotherapy or next-generation hormonal agent for metastatic castration-resistant prostate cancer.
– Has not recovered from previous major surgery or has ongoing surgical complications.
– Has received prior treatment with Radium for prostate cancer.
– Has received CYP450-inducing antiepileptic drugs for seizure.
– Has received radiotherapy within 2 weeks prior to first dose of study drug.
– Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study drug.
– Has received prior systemic therapy including other investigational drugs, or investigational devices within 4 weeks prior to first dose of study drug.
– Has received a live or live-attenuated vaccine within 30 days prior to first dose of study drug.
– Has known hypersensitivity to components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide.
– Has known other malignancy that is progressing or has required active treatment within the past 3 years.
– Is receiving chronic systemic steroid therapy (>10mg / day of prednisone or equivalent).
– Has known central nervous system metastases. Patients with previously treated brain Mets may participate if they have been radiologically stable for 4 weeks and have not required steroid treatment for at least 14 days prior to first dose of study drug.
– Has active autoimmune disease that required systemic treatment in the last 2 years.
– Has active infection that requires treatment.
– Has concurrent Hepatitis B and Hepatitis C virus infection.
– Additional criteria may apply and will be discussed with the study team and physician.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
AK112-301: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi).
Principal Investigator: Kurt Demel, MD
Study sponsor: Summit Therapeutics Sub, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This study is randomized, meaning you have an equal chance to be placed in either the study drug arm, or the placebo arm. The study is split into two arms: Arm 1 is the study drug (Ivonescimab, or AK112) combined with the drugs Pemetrexed and Carboplatin. Arm 2 is Placebo combined with Pemetrexed and Carboplatin. Since both arms are receiving Pemetrexed and Carboplatin, you will still be receiving some form of treatment for your disease regardless of what arm you are assigned. The main purpose of the study is to compare the overall survival and progression-free survival between the two arms. The study drug is an antibody. Antibodies are substances that occur naturally in the body and help fight infection. The study drug blocks two proteins in the body that help cancer cells live, grow, and spread. It is possible that the study drug may slow the growth and spread of cancer cells.
Inclusion Criteria:
– Must sign written informed consent.
– Must be at least 18 years old at the time of consent.
– ECOG of 0 – 1.
– Expected survival of at least 3 months.
– Confirmed locally advanced (stage IIIB / IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer.
– EGFR mutation as confirmed by tumor testing.
– Prior treatment with EGFR TKIs and treatment failure.
– At least 1 measurable noncerebral lesion per RECIST 1.1.
– Adequate organ function as determined by local lab tests.
– Negative serum pregnancy test within 3 days prior to first dose for women of child-bearing potential (WOCBP).
– WOCBP and their partners must agree to highly effective contraceptive use during the duration of the study and for at least 120 days following the last dose.
– Additional criteria may apply and will be discussed with the physician and research team.
Additional inclusion criteria may apply and will be discussed in greater detail with research team and physician.
Exclusion Criteria:
– Evidence of small cell carcinoma component, or predominantly squamous cell carcinoma.
– Previously received immunotherapy including anti-PD-1/PD-L1 antibodies, anti-CTLA4, and immune-checkpoint agonists, immune cell therapy.
– Received systemic antitumor therapy or antiangiogenic therapy other than EGFR inhibitors.
– Enrolled in another clinical trial, unless it is a non-interventional study or the follow-up period of an interventional study, and is more than 4 weeks from the last dose of the prior clinical study drug administration.
– Received EGFR inhibitor therapy within 2 weeks prior to first dose.
– Imaging during the screening period showing tumor growth around important blood vessels, that in the physician’s opinion could be a concern for bleeding risks.
– Symptomatic brain metastases.
– Other malignant tumors besides NSCLC within 3 years prior to first dose.
– Active autoimmune disease requiring systemic therapy within 2 prior to first dose. *Replacement therapy such as insulin or corticosteroid replacement therapy (prednisone <10mg per day or equivalent) for adrenal or pituitary insufficiency is allowed.
– History of major diseases within 1 year before first dose
– Major surgical procedures or severe infections within 4 weeks prior to first dose.
– History of severe bleeding.
– Current hypertension, uncontrolled hyperglycemia, presence of pleural effusions, pericardial effusions, ascites requiring multiple drainage, history of noninfectious pneumonia,
– Active or history of IBD (such as Crohn’s disease, ulcerative colitis)
– History of immunodeficiency; HIV test positive.
– History of Allogenic organ transplant or hematopoietic stem cell transplant.
– Untreated Hepatitis B, active Hepatitis C
– Known active tuberculosis
– Active Syphilis
– Unresolved toxicities from previous treatments that have not returned to baseline.
– Other exclusion criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, 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:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@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:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
HARMONi-3 Study: A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the first-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Principal Investigator: Kurt Demel, MD
Study sponsor: Summit Therapeutics Sub, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This is a randomized study – meaning you have a random chance to be assigned to either the study drug arm, which is Ivonescimab (study drug) + chemotherapy, OR to the standard arm, which is Pembrolizumab (Keytruda) + chemotherapy. The main purpose of the study is to look at overall survival of patients that are taking the study drug plus chemo, vs. the patients taking pembrolizumab plus chemo. The study drug works by attacking or interfering with 2 different parts of cancer growth at the same time. It interferes with the development of new blood vessels to the tumor, and also stimulates the body’s immune system to better identify cancer cells and destroy them.
Inclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Exclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HC366-RC2311: A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma
Principal Investigator: Brian Rank, MD
Study Sponsor: HiberCell Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This study is looking to test the safety and effectiveness, and to find the highest tolerated dose of study drug HC-7366 as single drug or in combination with Belzutifan (Welireg) in patients with Renal Cell Carcinoma. The study has two parts – a dose escalation phase (Finding the highest tolerated dose), and a dose expansion phase (further testing at the highest dose). The study drug works by interfering with cancer cells’ ability to feed themselves and potentially prevent their growth.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have confirmed diagnosis of metastatic Renal Cell Carcinoma.
– Must have progressive disease after receiving at least 2, and no more than 5 prior therapies for stage 4 disease.
– Must have at least 1 measurable lesion per RECIST 1.1.
– Has no RCC tumor that requires immediate surgery.
– If reasonably accessible with minimal risk and patient willing, at least one biopsy at baseline and another at cycle 2 day 1.
– Must have ECOG of 0-1.
– Has adequate organ function as determined by lab tests.
– Must not experience more than 10% weight loss in the last 4 weeks prior to starting study drug.
– Must have at least a 3-month life expectancy as determined by treating physician.
– If female patient of childbearing potential, must agree to highly contraceptive method or maintain abstinence from intercourse during the trial period and at least 90 days following the last dose of study drug. Also must have negative serum pregnancy test at screening.
– Male patients must abstain from intercourse or agree to using highly contraceptive methods during trial period and at least 90 days after the last dose of study drug.
– Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Patient is excluded if they have had prior treatment with Belzutifan or other HIF-2α inhibitor.
– Has received any type of small molecule kinase inhibitor within 2 weeks prior to study.
– Is currently receiving an investigational drug or device within 4 weeks prior to starting study.
– Has received radiotherapy within 2 weeks prior to study. Patient must have recovered from radiotherapy related toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation to non-Central Nervous System disease.
– Is immunodeficient or receiving systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Has any of the following: Pulse oximeter reading of <92%, requires intermittent supplemental or chronic supplemental oxygen.
– Has history of lung disease or pneumonitis within 12 months prior to screening.
– Has clinically significant cardiovascular disease within 6 months from first study drug administration (specifics to be discussed with physician/study team).
– Has additional known malignancy that is progressing or has required active treatment within the last 5 years. Basal cell or squamous cell carcinoma are excluded. Other malignancies are also eligible if they were cured by surgery alone, surgery plus radiotherapy and have been disease free for at least 5 years.
– Has history of, or active central nervous system metastasis. May be able to participate if CNS is radiologically stable for at least 4 weeks and no evidence of enlargement.
– Has moderate to severe Child-Pugh B or C.
– Has known hypersensitivity to active ingredients of study drug or Belzutifan.
– Has history or retinitis or photosensitive skin disorders.
– Has history of severe autoimmune disease or history of organ transplant.
– Is unable to swallow oral medications or has evidence of GI disorder that may impact drug absorption.
– Has known active HIV or Hepatitis B or C.
– Is currently receiving strong or moderate Inducers or Inhibitors of Cytochrome P450 (CYP3A4) that cannot be discontinued during the study.
– Has a history of, or any other active condition that, in the opinion of the investigator, would interfere with the individual’s ability to cooperate with the study requirements.
– Other exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@parknicollet.com
HLX10-005-SCLC301-E: A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Principal Investigator: Yan Ji, MD
Study Sponsor: Shanghai Henlius Biotech
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: This is a Phase 3 study that is looking to study the effects of the study drug HLX10 combined with chemotherapy on extensive-stage small-cell lung cancer. Patients are randomly assigned to either the experimental arm – the study drug + chemotherapy, or the control arm – Atezolizumab (Tecentriq) + chemotherapy. The study drug works by targeting PD-1, and helps restore the body’s function to recognize and combat cancer cells.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must be diagnosed with extensive-stage small-cell lung cancer.
– Must not have had any previous therapy for ES-SCLC
– Patients that received chemoradiotherapy for limited stage SCLC must be treated with curative intent and must have treatment-free period of at least 6 months from the last course of chemo, radiotherapy, or chemoradiotherapy until diagnosis of extensive stage SCLC.
– Must have at least 1 measurable lesion per RECIST 1.1.
– ECOG of 0 – 1.
– Expected survival of at least 12 weeks.
– Normal organ function as determined by screening lab tests.
– Female patients may meet any of the following: Menopause (menses for at least 1 year), or surgically sterilized, or, if of childbearing potential, must have negative serum pregnancy test within 7 days prior to being randomized to the study, and must agree to using highly contraceptive methods while on study treatment. Additionally, must not be breastfeeding.
– Male patients must agree to abstinence or take contraceptive measures through 6 months post last dose of study treatment.
– Additional criteria may apply, and will be discussed with the physician and study team.
Exclusion Criteria:
– Confirmed mixed small-cell lung cancer.
– Other active malignancies within 5 years or at the same time.
– Patients who are preparing for, or have received an organ or bone marrow transplant.
– Pleural or pericardial effusion requiring intervention, or ascites.
– Patients with known Central Nervous System metastases and/or meningitis at screening. The following will be allowed: subjects with asymptomatic brain metastases – will be required to have regular brain imaging done. Subjects with treated brain mets that have been stable for at least 2 months and with discontinued steroids 3 days prior to study start.
– Patients with spinal cord compression that has not been treated with surgery or radiotherapy.
– Patients with myocardial infarct within half a year prior to first dose, or with poorly controlled arrhythmias.
– Class 3 or 4 cardiac insufficiency or LVEF <50%.
– Uncontrolled or symptomatic hypercalcemia.
– Grade 2+ peripheral neuropathy
– HIV infection or positive test for HIV antibody.
– Active pulmonary tuberculosis.
– Previous and current pneumonia, pneumoconiosis, radiation pneumonitis or impaired pulmonary function that, in the opinion of the physician, may interfere with detection and management of study drug-related pulmonary side effects.
– Hepatitis B or C infection.
– Known active or suspected autoimmune diseases. Patients that are stable and that do not need immunosuppressant therapy are allowed to enroll.
– Treatment with live vaccines, COVID-19 vaccine, within 28-days prior to study drug administration. Inactivated viral vaccines for seasonal flu are allowed.
– Patients that are requiring treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to first dose. (Subjects are allowed to use topical or inhaled steroids, and adrenal hormone replacement therapy at less than or equal to 10mg/day of prednisone or similar).
– Active infection requiring systemic therapy within 14 days prior to study drug administration. Patients with history of Covid-19 infection must have negative PCR test prior to first dose of study drug.
– Major surgery within 28 days or radiation within 3 months prior to study start.
– Patient has previously received other immune-checkpoint inhibitors such as PD-1, PD-L1, CTLA4.
– Is currently participating in another ongoing clinical trial or is less than 14 days from the end of a previous clinical trial treatment.
– Has known history of allergy to any monoclonal antibody, or known hypersensitivity to carboplatin or etoposide.
– Additional criteria may apply, and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
LCCC 1710: Feasibility of Collecting and Adjusting Patient-Reported Outcomes for Quality Reporting in Chemotherapy.
Principal Investigator: Dylan Zylla, MD
Study sponsor: Lineberger Comprehensive Cancer Center
Location: HealthPartners Frauenshuh Cancer Center
Purpose of study: This is a quality of life/supportive care study, which means this study does not provide any treatment as part of the study procedures. Instead, patients receiving standard anticancer treatment will answer a questionnaire 5-15 days after the treatment day. The purpose of the study is to test the questionnaire that asks about the symptoms that patients experience following their treatment.
Inclusion Criteria:
– Adults 21+
– Currently starting a systemic cancer treatment (Chemo, neoadjuvant chemo, immunotherapy, and/or targeted therapy)
– Is willing to complete a questionnaire 5-15 days after administration of treatment.
– Is able to complete the questionnaire in English, Spanish, or Mandarin Chinese.
Exclusion Criteria:
– Inability to provide informed consent
– Only receiving hormonal treatment without chemotherapy
– Is participating in a clinical trial involving an experimental drug.
Study Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@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:
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@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
Nimbus 1150-101: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors
Principal Investigator: Kurt Demel, MD
Study Sponsor: Nimbus Saturn Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I
Purpose of study: The purpose of the study is to look at how effective the study drug NDI-101150 is at treating certain cancer types when it is given as a single drug, or in combination with pembrolizumab (keytruda). The drug works by blocking a protein called HPK1, and this can potentially help the immune system to better recognize and destroy cancer cells. The study is made up of a dose escalation phase, where any solid tumors are accepted, and a dose expansion phase, where only select tumor types are eligible.
Inclusion Criteria:
– Must be 18 years or older at time of signing consent.
– Must have measurable disease via RECIST 1.1.
– Must have recovered from prior therapy (be at Grade 1 or baseline).
– ECOG of 0 – 1.
– Adequate organ function as determined by screening lab tests.
– Female patients that are women of child-bearing potential (WOCBP) must agree to using highly effective contraceptive methods while on study and must have negative serum or urine pregnancy test within 48hrs prior to Cycle 1 Day 1 of study treatment.
– Must be able to swallow study medication.
– Be willing to avoid sun exposure, wear protective clothing, and/or apply sunscreen if sun exposure is unavoidable.
– For Dose Escalation portion of the study: must have advanced or metastatic solid tumors for which no standard therapies are available or must be refractory to standard therapy.
The Following inclusion criteria are for the dose expansion phase, and are in addition to the criteria listed above:
– Must be willing to consent to required tissue biopsy.
– Must have advanced or metastatic Gastric/Gastroesophageal junction, Non-small cell lung cancer, or Renal Cell Carcinoma for which there is no standard therapy available.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Had a previous solid organ or hematopoietic stem cell transplant.
– Central Nervous System disease that is previously untreated or requires steroids or other intervention.
– Prior anti-cancer treatment that includes the following: Systemic anticancer treatment – chemotherapy, antibody or other anticancer therapy less than 4 weeks prior to first dose of study treatment. Radiation therapy, stereotactic body radiation, chemoembolization, small molecule therapy or targeted therapies.
– Significant cardiovascular disease: myocardial infarct/stroke, or unstable angina within 3 months prior to study treatment, Congestive Heart Failure, uncontrolled hypertension, or history of significant ventricular arrhythmias.
– History of severe immune-related adverse events that led to stopping of prior immunotherapy.
– History of severe hypersensitivity reaction to treatment with monoclonal antibodies.
– If patient requires corticosteroids >10mg/day prednisone or equivalent within 14 days prior to day 1. (Some exceptions may apply
– History of lung disease, pneumonitis, or pneumonia on chest scan within the last 6 months.
– Major surgery within 4 weeks prior to starting study drug, or if patient has not recovered from effects of the prior surgery.
– Uncontrolled active infection that requires IV antibiotics, antiviral, or antifungal medication within 14 days prior to study treatment.
– Known additional active malignancy that is requiring treatment (excluding basal cell, or squamous cell skin cancer, or other cancer for which patient has been disease free for more than 2 years).
– Active HIV infection, or Hepatitis B or C infection.
– Known current alcohol or drug abuse.
– unstable or uncontrolled condition, psychiatric illness, or abnormal lab finding that, in the opinion of the physician, would increase the risk to the patient.
– Prior treatment with an HPK1 inhibitor.
– Taking any contraindicated medications that cannot be discontinued prior to starting study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Piqray CGM IIT: Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib (CBYL719A0US16T)
Principal Investigator: Dylan Zylla, MD, Richard Bergenstal, MD
Study sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: The purpose of the study is to characterize and understand the impact of alpelisib on glucose control in patients with breast cancer using Continuous Glucose Monitoring (CGM) and following a hyperglycemia prevention and management regimen.
Inclusion Criteria:
– Adults age 18+ with diagnosis of metastatic Breast cancer that are initiating treatment with Alpelisib.
– Must be willing to and comply with study visits and procedures.
– Must meet standard clinical criteria for utilizing Alpelisib, including Hormone-receptor positive/HER2 negative cancer with presence of PIK3CA mutation.
– Treating oncologist must plan to use Alpelisib until disease progression or unacceptable toxicity.
– Patient must receive cancer care with a HealthPartners Oncologist during Alpelisib treatment phase and must be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
– Must have compatible smartphone, access to compatible smartphone, or ability to digitally upload information from Continuous Glucose Monitor (CGM), or to bring the reader in to the medical visit at least once a month for uploading data.
– Must have life expectancy of at least 3 months.
Exclusion Criteria:
– Has known history or allergy to skin-adhesive material, or previous cutaneous reaction to a continuous glucose monitor.
– Known currently uncontrolled diabetes, defined as most recent HbA1c over 10%, or history of DKA within 6 months prior to enrollment.
– Concurrent use of high-dose vitamin C, defined as more than 1g of oral vitamin C daily, or IV vitamin C infusions.
– Any concurrent severe, or uncontrolled condition that, in the opinion of the investigator, would cause safety risk, compromise protocol compliance, or contraindicate patient’s participation in the study.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
Preserve-003: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors.
Principal Investigator: Dylan Zylla, MD
Study sponsor: OncoC4, Inc., BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This research study is a Phase 3 clinical trial, which tests the effects of ONC-392 for the treatment of lung cancer compared to a standard of care chemotherapy drug, docetaxel. The most important measurement for the study is to see how long the treatment could prolong your life. ONC-392 is an investigational drug being developed as an anti-tumor treatment.
ONC-392 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule (protein) is called CTLA-4. ONC-392 binds to CTLA-4 and acts to reduce the regulatory immune cells and to let normal immune cells get into the tumor mass to fight against the tumor. ONC-392 has been tested in early Phase 1 and Phase 2 ongoing studies since 2020. This study will enroll participants who have non-small cell lung cancer and have disease progression after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 based immunotherapy. You will be randomized to receive either ONC-392 or the currently FDA approved standard of care chemotherapy agent docetaxel.
Inclusion Criteria:
– Must be at least 18 years old
– Must have histologically or cytologically confirmed diagnosis of metastatic non small-cell lung cancer (metastasis can be regional lymph nodes or distant organs).
– Progression of disease with most recent line of treatment for 3a or 3b: a) at least 12 weeks of standard dose of PD-1/PD-L1 inhibitor in combination with platinum chemo, b) Prior treatment with at least 2 cycles of platinum chemo followed by 12 weeks of standard PD-1/PD-L1 immunotherapy.
– Must have measurable disease via RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have adequate organ function as determined by local lab tests.
– Must have at least a 3-month life expectancy.
– Sexually active Women of childbearing potential (WOCBP) must agree to highly effective contraceptive use starting at screening and continuing through 90 days after last dose of study drug.
– Sexually active male patients must agree to highly effective contraceptive methods from screening through 90-days after last dose.
– Must agree to allow study team to access archival tissue/ or treatment tissue from biopsy or surgery.
Exclusion Criteria:
– Any patient that has not recovered to baseline from previous anticancer therapy.
– Any patient currently enrolled in another clinical trial that is testing an investigational drug or device, or an approved systemic therapy that contains anti-PD-1/ anti-PD-L1 within the last 28 days prior to first day of study treatment.
– Patients with chronic steroid therapy of greater than 10mg per day or prednisone or equivalent within 7 days prior to first dose of study drug.
– Patients with documented mutations or genetic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK, or HER2.
– Patients with active of symptomatic brain metastasis or evidence of progression within 4 weeks prior to study drug.
– Patients with active GI disease such as Inflammatory Bowel Disease, diverticulitis, pancreatitis, or peptic ulcer disease, etc are excluded.
– Patients with current, active, or prior history of Interstitial lung disease, or pneumonitis, that required high dose steroids.
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
STAR-221: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Principal Investigator: Rachel Lerner, MD
Study sponsor: Arcus Biosciences, Gilead
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: The purpose of the study is to test the effectiveness of using the drugs Domvanalimab and Zimberelimab in combination with Chemotherapy to treat your type of cancer, compared to the effectiveness of standard of care Nivolumab and Chemotherapy. Since this is a treatment study, you will be randomly assigned to either the standard of care arm, or the experimental arm.
Inclusion Criteria:
Participant must:
– Be at least 18 years or older
– Be diagnosed with any of the following cancer types; locally advanced unresectable or metastatic gastric cancer, Gastroesophageal Junction, or esophageal adenocarcinoma
– Have an ECOG status of 0-1
– Have at least 1 measurable target lesion per RECIST v1.1
Exclusion Criteria:
– Excluded if the patient has an underlying medical condition such as, but not limited to, the following; history of lung disease or non-infectious pneumonitis, Cardiac Disease NYHA class II or greater, unstable or newly-onset Angina within 3 months of randomization.
– Has had a history of solid-organ transplant or allogenic bone marrow transplantation.
– Has dementia, or a psychiatric or substance abuse condition that would interfere with participants ability to satisfy study requirements.
– Has known HER-2 positive tumor.
– Has untreated, symptomatic, or actively progressing brain metastasis
– Has been previously treated for metastatic gastric, GEJ, or esophageal adenocarcinoma.
– Has had disease progress within 6-months while on neoadjuvant or adjuvant chemotherapy.
*Additional inclusion/exclusion may apply and will be discussed with the provider or research team.
Study Contact
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
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
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 30 and 70 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: Randy Hurley, MD
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
XTX301-01/02-001: A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Principal Investigator: Jayanthi Vijayakumar, MD
Study sponsor: Xilio Development Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The main purpose of this study is to determine if XTX301 is safe and well-tolerated in participants with advanced solid tumors. This is the first time XTX301 is going to be given to humans, so this study will also serve to determine the recommended XTX301 dose and schedule in later clinical studies.
Inclusion Criteria:
– Patient must be at least 18 years or older at time of consent.
– Must meet the following disease criteria:
a. Part 1A – any confirmed solid tumor that is locally advanced or metastatic that has failed standard treatments, or for which there is no standard therapy available.
b. Part 1B – Locally advanced or metastatic tumor that is any of the following: Melanoma, non-small cell lung cancer (NSCLC), Head and Neck Squamous cell, Triple-negative breast (TNBC), Cervical cancer, MSI-H/dMMR colorectal, or MSI-H/dMMR endometrial cancer.
– Patient must not have received prior anticancer therapy for at least 28 days prior to starting study treatment, and must have returned to baseline or grade 1 for any side effects from previous therapy.
– Must have ECOG of 0-2.
– Patient must have adequate organ function as determined by local lab tests.
– For Part 1B only: patients must be willing to undergo a tumor biopsy before starting, and while on study treatment.
– Women of Childbearing Potential (WOCBP) must be willing to abstain from sexual activity, or use highly effective contraception. Additionally, must also have a negative serum pregnancy test at the time of study enrollment and before each dose of study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Must not have had previous treatment with IL-12 therapy
– Patients with known liver metastasis are excluded, unless previous discussion between treating physician and study medical monitor approves the patient to enroll.
– Concurrent anticancer therapy, immune therapy, or cytokine therapy, or other antineoplastic therapy during the study.
– History of significant pulmonary disease, interstitial lung disease or pulmonary fibrosis.
– History of significant heart disease, uncontrolled hypertension, congestive heart failure, or myocarditis.
– Possible area of non-disease related necrosis, such as an active ulcer, a non-healing wound, or intercurrent bone disease.
– Has active central nervus metastases, or carcinomatous meningitis.
– Active autoimmune disease that required therapy in the past 2 years, including use of corticosteroids, or immunosuppressive drugs.
– Has an active infection that requires systemic therapy within 4 weeks prior to receiving study drug.
– Has a history of Grade 3 or higher immune-related toxicities from prior immunotherapy unless it resolved within 14 days.
– Has had history of severe hypersensitivity to monoclonal antibodies
– Is pregnant or breastfeeding.
– Has active hepatitis B or C infection.
– Has had prior gene therapy treatment, organ transplant, or hematopoietic stem-cell transplant.
– Is currently using or has received another investigational drug or device within 4 weeks prior to starting study drug.
– Has received a live or live-attenuated vaccine within 4 weeks prior to first dose.
– Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
