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Study of Evofosfamide, Zalifrelimab, and Balstilimab for Advanced Cancers

This study is testing three investigational drugs together: evofosfamide, zalifrelimab, and balstilimab. Researchers want to see how safe and effective this combination is for people with advanced or metastatic (spread to other parts of the body) castration-resistant prostate cancer, pancreatic cancer, or HPV-negative head and neck squamous cell carcinoma. The study aims to find the best dose of evofosfamide when given with zalifrelimab and balstilimab. These drugs work by targeting specific pathways in the body to fight cancer. You may be able to join if you have one of these cancers and other standard treatments are not available or appropriate for you. The study plans to enroll 71 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It will determine the maximum tolerated dose of the drug combination and then evaluate its effectiveness in three different cancer groups.
What's involved
Evofosfamide is given on Days 1 and 8 of Cycles 1, 2, and 3. Zalifrelimab is given on Day 8 of Cycles 1, 3, and 5. Balstilimab is given every 2 weeks starting on Day 8 of Cycle 1.
Compensation
Not stated in the trial record.
Follow-up
The incidence and severity of side effects, including dose-limiting toxicities, will be measured at 12 months.

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NCT06782555

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

Recruiting
PHASE1Ages 18+InterventionalTreatment
ImmunoGenesis
~71 participants
Updated 2025-01-21 on ClinicalTrials.gov
What's tested:EvofosfamideZalifrelimabBalstilimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events including dose-limiting toxicities
Measured over 12 months

Conditions

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

Explore related trials

Head and Neck Squamous Cell CarcinomaPancreatic CarcinomaProstate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Charles Schweizer, PhD
[email protected]
346-772-0336
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least ≥4.0 ng/mL.
New or increasing non-bone disease per RECIST 1.1 criteria.
Positive bone scan with 2 or more new lesions (PCWG3). 5. Adequate bone marrow function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:
White blood cell count ≥2500 cells/mm3.
Absolute neutrophil count ≥1500 cells/mm3.
Absolute lymphocyte count \>500 cells/mm3.
Hemoglobin ≥9 g/dL.
Platelets ≥75,000 cells/mm3. 6. Adequate liver function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:
Bilirubin ≤1.5 × institutional ULN; for patients with known Gilbert's syndrome, ≤3 × institutional ULN.
Aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) ≤3 × institutional ULN; if liver metastases are present, then ≤5 × ULN is allowed. 7. At least 3 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is shorter, from targeted or biologic therapy with the exception of CTLA-4, PD-1, or PD-L1 blocking antibodies for which only a 2 week interval is required. Patients with prostate cancer, unless they have undergone prior orchiectomy, may continue to receive androgen deprivation therapy, anti-androgen therapy, or therapy that interferes with androgenic stimulation. 8. All patients must be willing to undergo a biopsy to provide a new tumor sample within 14 days of Cycle 1 Day 1. Patients who are unable to undergo a biopsy at screening must submit archival tumor tissue retrieved within the last 6 calendar months. Patients must also consent to undergo a biopsy between Day 15 of Cycle 2 and Day 8 of Cycle 3 in those subjects which it is clinically safe and attainable. A biopsy is not required for participants with metastatic prostate cancer with bone-only disease or inaccessible soft tissue lesions. 9. Calculated creatinine clearance ≥ 60 mL/min (by the Cockcroft Gault formula) within 7 days of Cycle 1 Day 1

What this trial measures

  • Incidence and severity of adverse events including dose-limiting toxicities12 months