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: Regions Cancer Care Center
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, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors (PSB205-201)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Qilu Puget Sound Biotherapeutics Corporation
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a study of a drug called PSB205 for the treatment of solid tumors. PSB205 works in two ways and can cause fewer potential side effects than those caused by the combination of Nivolumab and Ipilimumab. PSB205 has been shown to have the same effect on tumors as the combination of Nivolumab and Ipilimumab.
Inclusion Criteria:
-Patients aged 18 years or older.
-ECOG Performance status of less than or equal to 2.
-Life expectancy of greater than or equal to 3 months.
-Adequate bone marrow, organ function and laboratory parameters.
-Female subjects who are not pregnant or breastfeeding.
-Recovered from all reversible AEs due to previous anticancer therapies.
-Suitable venous access for the study required blood sampling.
-Must have one of the following solid tumors: Advanced or metastatic clear cell RCC or non-clear cell RCC, urothelial cancer, small cell lung cancer, advanced soft tissue or bone sarcoma, metastatic melanoma, or mismatch-repair-deficient malignancies.
Exclusion Criteria:
-Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years.
-Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.
-Hypertension unable to be controlled with medication.
-Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
-Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.
-Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
-Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
-Subjects with a history of organ transplant.
-Hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.
-Known human immunodeficiency virus (HIV) positive.
Study Contact:
Lisa Wahowske, RN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Subjects with Advanced/Unresectable Urothelial Cancer (GU15-215)
Principal Investigator: Arek Dudek, MD, PhD
Study Sponsor: Hoosier Cancer Research Network
Location: Regions Cancer Care Center (Regions Hospital)
Phase of Study: Phase 2
Purpose of Study:
The purpose of this study is to evaluate any good and bad effects of treating your different types of urothelial cancer with atezolizumab plus bevacizumab. Atezolizumab is already an FDA approved treatment for advanced urothelial cancer for people who cannot safely receive cisplatin chemotherapy, and this study will assess the effect (good or bad) of adding bevacizumab to atezolizumab. Bevacizumab is not FDA approved standard treatment for urothelial cell carcinoma. In this study, you will receive atezolizumab plus bevacizumab as the first treatment for your advanced urothelial cancer. Bevacizumab plus atezolizumab has been shown to be safe in previous studies in patients with other type of cancers. The study doctors would like to determine if the combination of atezolizumab and bevacizumab is more effective in controlling your cancer.
Inclusion Criteria:
– Age ≥ 18 years.
– ECOG Performance Status 0, 1 or 2 within 28 days prior to randomization.
– Histologic or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra.
– Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease.
– Willing to undergo a core needle or excisional biopsy on-treatment.
Exclusion Criteria:
– Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment.
– Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment.
– Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments.
– Leptomeningeal disease.
– Uncontrolled tumor-related pain.
– Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(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: Frauenshuh Cancer Center, Regions Cancer Care Center
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:
- 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
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: Regions Cancer Care Center
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
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: Regions Cancer Care Center
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
NEKTAR PROPEL 16-214-05 A Phase 1b Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combo with Anti-PD1 (Pembro) or Anti-PDL1 (Atezolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors
Principal Investigator: Rachel Lerner, MD
Study Sponsor: Nektar Therapeutics
Location: Frauenshuh Cancer Center
Phase of Study: Phase 1
Purpose of Study:
To test the safety, tolerability, and effectiveness (how well these drugs work together) of NKTR-214 given in combination with pembrolizumab or atezolizumab. We want to find out what effects, good or bad, the study drug has on you and your cancer when combined with pembrolizumab or atezolizumab.
NTKR-214 is a modified (changed in the laboratory) form of a protein called interleukin-2 (or IL-2) which is normally made by your immune system. This protein is designed to trigger (wake up) other cells in your immune system to start attacking your cancer cells. IL-2 has been used for certain cancers for many years so doctors understand many of the risks and benefits.
Pembrolizumab and atezolizumab are prescription medicines used to treat locally advanced or metastatic (has spread into different areas of the body) melanoma, locally advanced or metastatic urothelial bladder cancer or metastatic Stage 4 Non-small cell lung cancer (IV-NSCLC). They are antibodies (known as checkpoint inhibitors) that block a type of protein (PD-1 or PD-L1) that can prevent human immune cells (called T cells) from attacking cancer cells. Pembrolizumab blocks PD-1, and atezolizumab blocks PD-L1.
Inclusion Criteria:
– Histologically confirmed locally advanced melanoma (pembrolizumab only), locally advanced or metastatic urothelial carcinoma, or metastatic NSCLC.
– Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
– Life expectancy > 12 weeks as determined by the Investigator.
– Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
– Measurable disease per RECIST 1.1.
– Patients must not have received prior oncology regimens, including but not limited to inhibitors such as anti PD-1, anti-PD-L1, anti-PD-L2, anti CD137, or anti CTLA-4 (cytotoxic T lymphocyte-associated protein 4) antibody, or any other antibody or drug specifically targeting T cell co stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies.
– MELANOMA patients: must have histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system
– MELANOMA patients: Ocular melanoma is excluded
– MELANOMA patients: Have not received prior anti-cancer therapy for advanced or metastatic melanoma
– MELANOMA patients: Patients with unknown BRAF mutation status may enroll so long as mutation testing is planned to be performed within 30 days of Cycle 1 Day 1
– NSCLC patients: Histologically confirmed or cytologically confirmed diagnosis of stage IV NSCLC
– NSCLC patients: First-line (pembrolizumab only), patients must have high PD-L1 expression (Tumor Proportion Score [TPS] ≥ 50%) as determined by FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
– NSCLC patients: Second-line (pembrolizumab or atezolizumab), patients must have experienced disease recurrence or progression during or after a prior platinum-based chemotherapy given for advanced or metastatic disease. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations and must not have received chemotherapy.
– If patient is to receive pembrolizumab in combination with NKTR 214, PD L1 expression by TPS should be ≥ 1% as determined by an FDA-approved test.
– UROTHELIAL CARCINOMA patients: Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma
– UROTHELIAL CARCINOMA patients: First-line (pembrolizumab only), patients who are not eligible for cisplatin-containing chemotherapy.
– UROTHELIAL CARCINOMA patients: First-line (atezolizumab only), patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.
– UROTHELIAL CARCINOMA patients: Second-line (pembrolizumab or atezolizumab), patients who have disease progression during or following platinum-containing chemotherapy.
– Additional criteria may apply.
Exclusion Criteria:
– Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
– Females who are pregnant or breastfeeding.
– Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves’ disease, Hashimoto’s disease, alopecia areata, eczema, or with Medical Monitor approval).
– History of allergy or hypersensitivity to study drug components.
– Active malignancy not related to the current diagnosed malignancy.
– History of organ transplant that requires use of immune suppressive agents.
– Use of warfarin within 14 days of initiating study drug(s). (Note: Low molecular weight heparin is allowed on the study.)
– Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
– Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
– Additional criteria may apply
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
TAK 981-1002: An Open Label, Dose-Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, of TAK-981 in Adult Patients with Metastatic Solid Tumors or Lympho-mas (TAK 981-1002)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Takeda Pharmaceuticals
Location: Regions Cancer Care Center
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
