Actively Recruiting
Phase 1/2 Study of Evofosfamide with Zalifrelimab and Balstilimab in Advanced Prostate, Pancreatic, and Head and Neck Cancers
Led by ImmunoGenesis · Updated on 2025-01-21
71
Participants Needed
1
Research Sites
155 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 investigating 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. This Phase 1/2 study is based on the idea that evofosfamide targets low-oxygen areas in tumors, which may improve the ability of immune therapies zalifrelimab and balstilimab to attack resistant tumors. The study has two parts. In the Phase 1 dose escalation phase, researchers will determine the highest safe dose of evofosfamide combined with zalifrelimab and balstilimab. Then, in Phase 2, the recommended dose will be tested in three groups of patients with the specified cancers. Evofosfamide is given on Days 1 and 8 during the first three treatment cycles. Zalifrelimab is given on Day 8 of treatment Cycles 1, 3, and 5. Balstilimab is administered every two weeks starting on Day 8 of the first cycle. Participants will undergo various assessments including scans and lab tests to monitor tumor response and safety throughout the study. Researchers will track adverse events and dose-limiting toxicities over 12 months. Biopsies are required before starting treatment and during early cycles if safe and possible. The study also monitors immune response and collects information on patient health status and treatment effects during the trial's duration.
CONDITIONS
Official 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 SCCHN with no standard therapy options available or appropriate
- 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 with documented progression
- Adequate bone marrow function with specified blood count thresholds within 7 days before treatment
- Adequate liver function with bilirubin and enzyme levels within specified limits within 7 days before treatment
- At least 3 weeks since prior chemotherapy or radiation, and appropriate intervals since targeted or biologic therapies
- Willingness to undergo a tumor biopsy within 14 days before treatment or provide recent archival tissue
- Creatinine clearance of 60 mL/min or higher 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 autoimmune vasculitis
- Prior Grade 3 or 4 adverse events from anti-CTLA-4, anti-PD-1/PD-L1 therapies
- History of diverticulitis, abdominal abscess, gastrointestinal obstruction, or risk factors for bowel perforation
- Use of long-term systemic steroids above 10 mg prednisone daily started more than 2 weeks before enrollment
- Underlying medical or psychiatric conditions that may affect treatment safety or assessment
- Use of QT-prolonging drugs or history of long QT syndrome
- Abnormal QTc interval above 470 msec
- Unstable blood pressure outside specified ranges
- Untreated or uncontrolled brain metastases or central nervous system cancer disease
- Uncontrolled illnesses including recent myocardial infarction, unstable heart disease, infections, or psychiatric conditions
- Recent major surgery, open biopsy, or significant injury within 4 weeks
- Active uncontrolled infections or serious medical conditions compromising study participation
- Active HIV infection except well-controlled cases on effective antiretroviral therapy
- Active or chronic hepatitis B or C infection without successful treatment
- Known allergies to study drugs or similar compounds
- Live vaccines within 4 weeks before enrollment
- Concomitant immunotherapies or immunosuppressive agents
- Use of strong or moderate CYP3A4 inhibitors or inducers within 14 days before enrollment
- Use of other anti-cancer therapies except allowed androgen deprivation or bone-targeted therapies for prostate cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here