Study on Avutometinib, Defactinib, and Cetuximab for Advanced Colorectal Cancer That Cannot Be Removed by Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06369259

Provider View

This clinical trial is testing a new combination of drugs—avutometinib, defactinib, and cetuximab—to see if they can help control advanced colorectal cancer that cannot be surgically removed and has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—avutometinib, defactinib, and cetuximab—can effectively treat advanced colorectal cancer that cannot be removed by surgery and has not responded to anti-EGFR treatments. Researchers will evaluate how well the treatment works, its safety, and how it affects the body.

Description

This study aims to test the effectiveness of a new drug combination for treating advanced colorectal cancer that cannot be surgically removed. The main goal is to see how well the treatment works in shrinking tumors. Researchers will also look at how the treatment affects patients' survival, its safety, and how it interacts with the body. They will explore how the drugs work together and look for signs that might predict how well the treatment will work. Additionally, the study will investigate why some cancers resist treatment and how to overcome this resistance.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
  • Cancer must be measurable by standard criteria.
  • Must have specific genetic markers (KRAS, NRAS, EGFR, BRAF V600E wild-type) at diagnosis.
  • Have received at least one prior chemotherapy treatment for metastatic colorectal cancer.
  • Have previously been treated with anti-EGFR therapy (cetuximab or panitumumab) for at least 16 weeks.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Must have recovered from any previous chemotherapy or radiotherapy side effects.
  • Have adequate blood cell counts and organ function.
  • Must be able to take oral medications.
  • If sexually active, must use effective contraception or be postmenopausal or surgically sterile.
  • Willing to participate and comply with all study requirements.

Exclusion Criteria

  • History of severe allergic reactions to cetuximab or similar drugs.
  • Have been treated with ERK1/2, MEK, or BRAF inhibitors.
  • Have known symptomatic brain metastases.
  • Have a history of retinal vein occlusion or central serous retinopathy.
  • Have had another cancer within the last 3 years, except for certain non-threatening cancers.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have active infections requiring IV antibiotics or antifungals.
  • Have active HIV, hepatitis B, or hepatitis C infections.
  • Have gastrointestinal issues that affect drug absorption.
  • Have had major surgery within 6 weeks before starting the study.
  • Have received other cancer treatments recently.
  • Are pregnant or breastfeeding.
  • Have a history of rhabdomyolysis.
  • Have any condition that would make participation unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77807HoustonTexas

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