Phase 12 Study of Evofosfamide Combined with Zalifrelimab and Balstilimab for Advanced Prostate, Pancreatic, and HPV-Negative Head and Neck Cancers

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a combination of three investigational drugsevofosfamide, zalifrelimab, and balstilimabin 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 12 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.

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab