RecruitingPhase 1Phase 2NCT06782555

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


Sponsor

ImmunoGenesis

Enrollment

71 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of evofosfamide (a drug that activates inside low-oxygen tumor areas) with two immunotherapy drugs (zalifrelimab and balstilimab) in people with advanced castration-resistant prostate cancer, pancreatic cancer, or HPV-negative head and neck cancer. The combination aims to attack tumors that have been resistant to standard treatments. **You may be eligible if...** - You have advanced prostate, pancreatic, or head-and-neck cancer with no remaining standard treatment options - Your general health is fair to good (ECOG 0–2) - You have measurable or evaluable disease on imaging - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have uncontrolled serious infections or autoimmune conditions requiring systemic treatment - You have significant heart problems or clotting disorders - You have received prior immunotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEvofosfamide

Evofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.

DRUGZalifrelimab

Zalifrelimab administered on Day 8 of Cycles 1, 3, and 5.

DRUGBalstilimab

Balstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06782555


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