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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782555 on ClinicalTrials.gov