A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

Part of paid clinical trials in Houston, Texas.

Sponsor
ImmunoGenesis
Study ID
NCT06782555
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evofosfamide — DRUG
    Evofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.
  • Zalifrelimab — DRUG
    Zalifrelimab administered on Day 8 of Cycles 1, 3, and 5.
  • Balstilimab — DRUG
    Balstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.

Study Details

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).

Key Dates

Start date
Jan 8, 2025
Status verified
Jan 2025
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
71 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Castration-resistant prostate cancer
    Evofosfamide + zalifrelimab + balstilimab
  • Experimental: Pancreatic cancer
    Evofosfamide + zalifrelimab + balstilimab
  • Experimental: Human papilloma virus-negative squamous cell carcinoma of the head and neck
    Evofosfamide + zalifrelimab + balstilimab

Primary Outcome Measure

Incidence and severity of adverse events including dose-limiting toxicities [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
LiYing Jiang, CCRP
[email protected]
713-792-9191
David S. Hong, PhD

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

Related Studies