Actively Recruiting
A Phase 1/2 Immunotherapy Study of Evofosfamide Combined with Zalifrelimab and Balstilimab for Advanced Prostate, Pancreatic, and Head and Neck Cancers
Led by ImmunoGenesis · Updated on 2025-01-21
71
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
ImmunoGenesis
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a combination of three investigational drugs—evofosfamide, zalifrelimab, and balstilimab—in patients with advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and HPV-negative squamous cell carcinoma of the head and neck (SCCHN). The study aims to test whether evofosfamide, which targets low-oxygen areas within tumors, can improve the immune response when combined with immune checkpoint inhibitors zalifrelimab and balstilimab in tumors that are typically resistant to treatment. This is a Phase 1/2 clinical trial sponsored by ImmunoGenesis. During the Phase 1 dose escalation, the study will determine the maximum tolerated dose of evofosfamide combined with zalifrelimab and balstilimab and establish a recommended dose for Phase 2. The Phase 2 expansion will test this drug combination in three separate groups of patients with the specified cancers. Evofosfamide is given on Days 1 and 8 of Cycles 1, 2, and 3; zalifrelimab is administered on Day 8 of Cycles 1, 3, and 5; balstilimab is given every two weeks starting on Day 8 of Cycle 1. Each group receives the same treatment regimen independently. Participants will be monitored for side effects and treatment responses for 12 months. Researchers will assess adverse events, progression-free survival, overall survival, and tumor response using standardized criteria. Blood tests will be done to study how the drugs behave in the body and to detect any antibodies against the treatments. Safety will be closely watched, including dose-limiting toxicities, with regular evaluations throughout the study period. The total participation duration may extend up to one year.
CONDITIONS
Brief Title
A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative squamous cell carcinoma of the head and neck with no other standard therapy options.
- Estimated life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Measurable disease by RECIST 1.1 or evaluable disease for prostate cancer per PCWG3 criteria with documented progression.
- Adequate bone marrow function with specified blood counts within 7 days before treatment.
- Adequate liver function within 7 days before treatment.
- At least 3 weeks since prior chemotherapy or radiation; specific intervals for biologic therapies.
- Willingness to undergo tumor biopsy or provide recent tumor tissue.
- Creatinine clearance of at least 60 mL/min within 7 days before treatment.
You will not qualify if you...
- Active or uncontrolled autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, systemic sclerosis, lupus, or vasculitis.
- Prior severe adverse reactions to anti-CTLA-4, anti-PD-1/PD-L1 therapies.
- History of acute diverticulitis, abdominal abscess, gastrointestinal obstruction or related bowel risks.
- Use of long-term systemic steroids above 10 mg prednisone equivalent started more than 2 weeks before enrollment.
- Medical or psychiatric conditions that may interfere with treatment or assessment.
- Use of QT-prolonging drugs or history of long QT syndrome.
- Abnormal QTc interval or uncontrolled blood pressure.
- Untreated or uncontrolled brain metastases or central nervous system cancer involvement.
- Uncontrolled illnesses including recent heart attack, infections, or psychiatric/social issues limiting study compliance.
- Recent major surgery or significant injury within 4 weeks.
- Active uncontrolled infections or advanced liver disease.
- Active HIV infection except well-controlled cases on stable therapy.
- Active or chronic hepatitis B or C infection not meeting clearance criteria.
- Known hypersensitivity to study drugs or components.
- Recent live vaccine within 4 weeks.
- Use of other immunotherapies or immunosuppressants.
- Use of strong/moderate CYP3A4 inhibitors or inducers shortly before or during study.
- Concurrent anti-cancer chemotherapy, radiotherapy, or targeted therapies except allowed prostate cancer treatments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 15 weeks covering multiple cycles
Participants receive evofosfamide, zalifrelimab, and balstilimab according to the study schedule. Evofosfamide is given on Days 1 and 8 of Cycles 1, 2, and 3. Zalifrelimab is administered on Day 8 of Cycles 1, 3, and 5. Balstilimab is given every 2 weeks starting on Day 8 of Cycle 1.
Multiple visits aligned with dosing schedule over treatment cycles
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Charles Schweizer, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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