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Study of Adagrasib and Cetuximab for Patients with Advanced Colorectal Cancer with KRAS G12C Mutation After First-Line Therapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Advanced Colorectal Cancer that has a specific genetic change called the KRAS G12C Mutation. The trial is testing a new treatment approach using a combination of two medications: Adagrasib (also known by its code name MRTX849) and Cetuximab. These medications will be compared to standard chemotherapy treatments, which include combinations like FOLFIRI or mFOLFOX6. The purpose of the study is to see how effective the new combination is in treating patients whose cancer has progressed after receiving initial standard treatments.

Participants in the study will receive either the new combination of Adagrasib and Cetuximab or one of the standard chemotherapy treatments. The study will monitor how long patients live and how long they remain free from cancer progression. It will also look at other factors such as side effects, how well the cancer responds to treatment, and the quality of life of the participants. The study will last for a period of time, with regular check-ups and assessments to track the progress and effects of the treatments.

This trial is important for understanding if the new treatment combination can offer better outcomes for patients with Advanced Colorectal Cancer with the KRAS G12C Mutation. The results could potentially lead to new treatment options for this specific type of cancer, providing hope for improved management of the disease. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable data on the effectiveness of the treatments being tested.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals with a diagnosis of advanced colorectal cancer with a specific genetic mutation known as KRAS G12C.

    Eligibility requires prior treatment with a specific type of chemotherapy and documented disease progression.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving a combination of adagrasib and cetuximab, and the other receiving standard chemotherapy.

  3. Step 3

    Treatment administration

    For those in the adagrasib and cetuximab group, adagrasib is taken orally, while cetuximab is administered intravenously as a solution for infusion.

    Participants in the chemotherapy group receive either the FOLFIRI or mFOLFOX6 regimen, which includes drugs such as fluorouracil, oxaliplatin, calcium folinate, and irinotecan, all given intravenously.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess overall survival and progression-free survival.

    Secondary assessments include tracking any adverse events, measuring the response rate to treatment, and evaluating the duration of response.

  5. Step 5

    Quality of life evaluation

    Participants complete assessments to report outcomes related to their quality of life throughout the study.

  6. Step 6

    Study completion

    The study is estimated to conclude by May 25, 2025, with final evaluations conducted to determine the effectiveness of the treatments.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of colorectal cancer with a specific change in the KRAS gene, known as the **G12C mutation**. This means that the cancer cells have a particular genetic alteration.
  • The patient must have already received a first round of treatment for advanced colorectal cancer. This treatment should have included a type of chemotherapy that uses a drug called **fluoropyrimidine**, combined with either **oxaliplatin** or **irinotecan**. These are medications used to treat cancer.
  • The patient's cancer must have shown signs of getting worse, as seen in medical imaging tests, either during or after the first round of treatment.
  • Both male and female patients are eligible to participate in the study.
  • The study is open to adults, which typically means individuals who are 18 years or older.

Who cannot join the trial?

4 criteria

  • Patients who do not have **advanced colorectal cancer** with a specific genetic change called **KRAS G12C mutation** cannot participate.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who are not able to receive the treatments being tested in the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Adagrasib

    is a medication being studied for its potential to treat advanced colorectal cancer. It is specifically designed to target and inhibit the KRAS G12C mutation, which is a common mutation found in some cancer cells. By blocking this mutation, adagrasib aims to stop the growth and spread of cancer cells.

  • Cetuximab

    is a type of therapy known as a monoclonal antibody. It works by targeting a specific protein on the surface of cancer cells, known as the epidermal growth factor receptor (EGFR). By binding to this protein, cetuximab can help slow down or stop the growth of cancer cells.

  • FOLFIRI

    is a combination chemotherapy regimen used to treat colorectal cancer. It includes three different drugs: folinic acid, fluorouracil, and irinotecan. These drugs work together to kill cancer cells or stop them from dividing and growing.

  • mFOLFOX6

    is another combination chemotherapy regimen used in the treatment of colorectal cancer. It consists of folinic acid, fluorouracil, and oxaliplatin. This combination works by damaging the DNA of cancer cells, which prevents them from growing and dividing.

What is already known about the treatment

  • Adagrasib

    Adagrasib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced colorectal cancer with a specific KRAS G12C mutation. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for patients whose cancer has progressed after initial treatment. Adagrasib works by specifically targeting and inhibiting the KRAS G12C mutation, which is a driver of cancer cell growth. It is classified as a targeted cancer therapy.

  • Cetuximab

    Cetuximab is administered intravenously and is an established medication used in the treatment of certain types of cancer, including colorectal cancer. In the context of this trial, it is being combined with adagrasib to assess its effectiveness against advanced colorectal cancer with the KRAS G12C mutation. Cetuximab works by binding to the epidermal growth factor receptor (EGFR) on cancer cells, blocking signals that promote tumor growth. It is classified as a monoclonal antibody used in targeted cancer therapy.

Investigated diseases

Advanced Colorectal Cancer with KRAS G12C Mutation – This is a type of colorectal cancer characterized by a specific genetic mutation known as KRAS G12C. Colorectal cancer originates in the colon or rectum, which are parts of the large intestine. The KRAS G12C mutation affects the KRAS gene, which plays a role in cell division and growth. This mutation can lead to uncontrolled cell growth, contributing to cancer progression. Advanced colorectal cancer indicates that the disease has spread beyond the initial site to other parts of the body. The progression of this cancer can vary, but it typically involves the growth and spread of cancerous cells, potentially affecting various organs and systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506241-30-00Protocol code849-010Estimated enrolment577 patientsSponsorMirati Therapeutics Inc.

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