NCT06782555

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: ImmunoGenesis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Tumor hypoxia can lead to poor effector T-cell penetration and immunosuppressive signaling via myeloid-derived suppressor cells, myofibroblasts, and regulatory T-cells. Disruption of these hypoxic regions within the tumor microenvironment by the hypoxia-directed cytotoxic agent evofosfamide may enhance the ability of immune checkpoint inhibitors to reject otherwise resistant solid tumors. The hypothesis tested in this study is that evofosfamide, by specifically targeting the hypoxic tumor microenvironment, may enhance the anti-tumor effects of the immune checkpoint inhibitors zalifrelimab (anti-CTLA-4) and balstilimab (anti-PD-1) in select tumors that are generally resistant to therapy. In the Phase 1 dose escalation part of the study, the maximum tolerated dose (or maximum allowable dose) of evofosfamide in combination with zalifrelimab and balstilimab will be determined. A recommended Phase 2 dose (RP2D) will be determined based on safety and the totality of data. The Phase 2 dose expansion part of the study will evaluate the Phase 2 dose of the triplet combination in 3 cohorts: 1) patients with locally advanced or metastatic castration-resistant prostate cancer; 2) patients with locally advanced or metastatic pancreatic cancer; and 3) patients with locally advanced or metastatic HPV-negative SCCHN. Each cohort expansion will be carried out independently.

Conditions

• Metastatic Prostate Cancer
• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-08
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2025-01-20
• Last updated: 2025-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study