Phase II Study of Ivonescimab for Previously Treated Metastatic Colorectal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06959550

Provider View

This clinical trial is testing a new drug, ivonescimab, to see if it can help control colorectal cancer that has spread and has already been treated with other therapies.

Patient Parameters

Program Overview

The purpose of this study is to find out if ivonescimab can help manage colorectal cancer that has spread to other parts of the body and has not responded to previous treatments. The study will also look at how safe the drug is for patients.

Description

The main goal of this study is to see how well ivonescimab works in patients with metastatic colorectal cancer that has not responded to other treatments. The study will focus on three groups of patients: those with a specific type of cancer that has not responded to certain immune therapies, those with cancer that has spread to the liver, and those without liver involvement. Researchers will also evaluate the safety of ivonescimab and explore how long it takes for the drug to work, how long the effects last, and overall survival rates. Additionally, the study will investigate any features of the cancer that might affect how well the drug works.

Eligibility Criteria

Inclusion Criteria

  • Must be able to give informed consent.
  • Adults aged 18 or older.
  • Have advanced colorectal cancer confirmed by lab tests.
  • Known status of specific cancer markers (MMR or MSI).
  • Specific criteria for each patient group:
    • Group 1: Cancer that has not responded to certain immune therapies.
    • Group 2: Cancer with liver metastases.
    • Group 3: Cancer without liver metastases.
  • Must have progressed after previous treatments or been intolerant to them.
  • Good overall health with specific blood and organ function levels.
  • Must have measurable disease.
  • Must provide a recent tumor sample.
  • Life expectancy of more than 3 months.
  • Women of childbearing potential and men must agree to use contraception during and after the study.

Exclusion Criteria

  • Previous treatment with certain immune therapies (except for specific cases).
  • Recent cancer treatment within 14 days before the study.
  • Unresolved significant side effects from previous treatments.
  • Recent serious heart or blood vessel issues.
  • Uncontrolled high blood pressure.
  • Active autoimmune or lung disease requiring treatment.
  • Recent severe infections or surgeries.
  • Active bleeding issues or certain medical conditions.
  • Pregnant or breastfeeding women.
  • Any condition that might interfere with the study or its results.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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