Study on Evofosfamide Combined with Zalifrelimab and Balstilimab for Advanced Cancers

Sponsor: ImmunoGenesis

Sponsor score: 0

ClinicalTrials ID:NCT06782555

Provider View

This clinical trial is testing a new combination of drugs—evofosfamide, zalifrelimab, and balstilimab—to see if they are safe and effective in treating advanced prostate cancer, pancreatic cancer, and certain head and neck cancers.

Patient Parameters

Program Overview

The study aims to find out if a new combination of drugs can help treat advanced or metastatic prostate cancer, pancreatic cancer, and head and neck cancer that do not respond to standard treatments. The drugs being tested are evofosfamide, which targets low-oxygen areas in tumors, and two immune system-boosting drugs, zalifrelimab and balstilimab. The study will first determine the safest dose of these drugs together, and then test their effectiveness in different groups of patients with these cancers.

Description

This study is exploring a new treatment approach for certain advanced cancers by combining three drugs: evofosfamide, zalifrelimab, and balstilimab. Evofosfamide targets low-oxygen areas in tumors, which can make it easier for the immune system to attack the cancer. Zalifrelimab and balstilimab are drugs that help the immune system recognize and fight cancer cells.

In the first part of the study, researchers will find the safest dose of these drugs when used together. In the second part, they will test this dose in three groups of patients: those with advanced prostate cancer, pancreatic cancer, and head and neck cancer. Each group will be studied separately to see how well the treatment works for each type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic prostate cancer, pancreatic cancer, or head and neck cancer that does not respond to standard treatments.
  • Be expected to live at least 3 more months.
  • Be in good enough health to perform daily activities with little or no assistance.
  • Have cancer that can be measured by scans or tests.
  • Have good bone marrow and liver function based on recent blood tests.
  • Have not received certain cancer treatments recently, with specific timeframes for each type.
  • Be willing to provide a new tumor sample or a recent one for testing.
  • Have good kidney function based on a specific test.

Exclusion Criteria

  • Have active or uncontrolled autoimmune diseases like rheumatoid arthritis or lupus.
  • Have had severe side effects from similar cancer treatments in the past.
  • Have certain digestive or abdominal conditions that increase the risk of complications.
  • Be on long-term high-dose steroids or have certain medical conditions that could interfere with the study.
  • Be taking medications that affect heart rhythm or have a history of heart rhythm issues.
  • Have uncontrolled high or low blood pressure.
  • Have untreated or unstable cancer in the brain.
  • Have had recent major surgery or a serious infection.
  • Have active HIV or hepatitis infections unless well-controlled.
  • Be allergic to any of the study drugs or their components.
  • Have received a live vaccine recently.
  • Be taking other cancer treatments or certain medications that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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