Actively Recruiting
A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
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
The purpose of this Phase 1/2 study is to test the overall safety, tolerability, and effectiveness of the combination investigational drugs evofosfamide, zalifrelimab, and balstilimab in treating advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and human papilloma virus (HPV)-negative squamous cell carcinoma of the head and neck (SCCHN).
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
CONTACT
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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