Study on VS-6766 and Cetuximab for Patients with Advanced Colorectal Cancer

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05200442

Provider View

This clinical trial is exploring the safety of combining two drugs, VS-6766 and cetuximab, for treating advanced colorectal cancer. It is for patients whose cancer has worsened despite previous treatments or who cannot tolerate those treatments. Participation may last up to 24 months.

Patient Parameters

Program Overview

The study aims to determine if the combination of VS-6766 and cetuximab is safe and effective for treating advanced colorectal cancer, especially in patients with specific genetic changes called KRAS mutations. Researchers want to see if this new combination works better than the usual treatments, which often include chemotherapy drugs like Fluorouracil (5-FU), oxaliplatin, and irinotecan, sometimes with bevacizumab. This study will focus on patients whose cancer has progressed despite these treatments or who cannot take them.

Description

This study is testing a new treatment approach for advanced colorectal cancer by combining two drugs, VS-6766 and cetuximab. The goal is to see if this combination is safe and can help control cancer better than standard treatments. The study is specifically for patients with certain genetic mutations in their cancer cells, known as KRAS mutations.

Participants will be monitored for safety and effectiveness of the treatment over a period of up to 24 months. The study will compare the new drug combination to the usual treatment options, which include various chemotherapy drugs. Researchers hope to find out if the new combination can offer better outcomes for patients with advanced colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced colorectal cancer with specific KRAS mutations.
  • Cancer must have worsened after standard treatments or there must be a valid reason for not having received them.
  • Must not have received certain previous treatments like Lonsurf or regorafenib.
  • Must not have had treatments targeting specific proteins like MEK or EGFR.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate heart function and meet specific lab test requirements.
  • Women must not be pregnant or nursing and must agree to use effective birth control.
  • Must not have untreated brain metastases.
  • Must not have had major surgery or other cancer treatments within two weeks before starting the study.

Exclusion Criteria

  • Must not have uncontrolled health issues like heart problems or infections.
  • Must not have had a recent heart attack or severe heart disease.
  • Must not have a history of certain heart rhythm problems.
  • Must not have had a recent COVID-19 infection.
  • Must not have certain muscle or skin disorders.
  • Must not have other cancers that could interfere with the study.
  • Must not have severe digestive issues that affect medication absorption.
  • Must not have certain eye conditions that increase risk during the study.
  • Must not have had a recent bowel perforation or fistula.
  • Must not have severe nerve damage.
  • Must not have had a stem cell or organ transplant.
  • Must not be allergic to study drugs or similar compounds.
  • Must not be taking certain medications that interfere with the study drugs.
  • Must avoid grapefruit and certain supplements during the study.

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