A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
NCT06782555 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2025-01-21
Summary
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
- Metastatic Prostate Cancer
- Metastatic Head and Neck Squamous Cell Carcinoma
- Metastatic Pancreatic Cancer
Interventions
- DRUG
-
Evofosfamide
Evofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.
- DRUG
-
Zalifrelimab
Zalifrelimab administered on Day 8 of Cycles 1, 3, and 5.
- DRUG
-
Balstilimab
Balstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.
Sponsors & Collaborators
-
Agenus Inc.
collaborator INDUSTRY -
ImmunoGenesis
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-08
- Primary Completion
- 2027-10-31
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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