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Study of BMS-986466 with Adagrasib and Cetuximab for Patients with KRAS G12C-mutant Advanced Solid Tumors

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 advanced solid tumors that have a specific mutation known as KRAS G12C. The types of cancer being studied include non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic duct adenocarcinoma (PDAC), and biliary tract cancer (BTC). The trial will test a new treatment combination involving a medication called BMS-986466 with another drug named adagrasib, and in some cases, a third drug called cetuximab. The purpose of the study is to determine if this combination is safe and effective for patients with these types of cancer.

The study is divided into two parts. In the first part, patients with advanced KRAS G12C mutant cancers will receive BMS-986466 with adagrasib, and some will also receive cetuximab. The goal is to find the safest dose that patients can tolerate. In the second part, the study will compare the effectiveness of the treatment combinations. For patients with NSCLC, the study will compare BMS-986466 with adagrasib against adagrasib alone. For those with CRC, the study will compare BMS-986466 with adagrasib and possibly cetuximab against adagrasib plus cetuximab.

Throughout the study, researchers will monitor for any side effects and measure how well the treatment works against the cancer. The study aims to identify the best dose levels for further testing and to see if the treatment can help control the cancer. The trial is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the presence of a KRAS G12C mutation in the cancer type you have, such as non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).

    If previous test results are unavailable, a central laboratory will confirm the mutation status.

  2. Step 2

    Treatment phase 1

    In the first part of the treatment, you will receive a combination of BMS-986466 and adagrasib. These medications are administered orally in capsule form.

    The goal is to determine the safe dosage levels and observe how well the treatment is tolerated.

  3. Step 3

    Treatment phase 1B

    If you have advanced CRC, you may receive an additional medication called cetuximab, which is administered intravenously.

    This phase aims to further assess the safety and effectiveness of the combination treatment.

  4. Step 4

    Treatment phase 2

    In the second part of the study, the effectiveness of the treatment will be evaluated. You may receive BMS-986466 with adagrasib or adagrasib alone, depending on your specific condition.

    For CRC patients, the treatment may include cetuximab as well.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring will occur to track your response to the treatment and any side effects. This includes routine check-ups and tests.

    The study will also measure the overall response rate and progression-free survival, which refers to the time during and after treatment that the cancer does not worsen.

Who can join the trial?

9 criteria

  • Participants must have a confirmed diagnosis of advanced cancer with a KRAS G12C mutation. This includes non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic duct adenocarcinoma (PDAC), and biliary tract cancer (BTC).
  • The cancer must have spread to other parts of the body and cannot be removed by surgery.
  • Participants may or may not have received previous treatment with KRAS G12C inhibitors (a type of cancer treatment targeting the KRAS G12C mutation).
  • For NSCLC and CRC, participants must have a documented KRAS G12C mutation from an approved test. If this result is not available, the mutation status should be confirmed by a central laboratory during screening.
  • For PDAC and BTC, participants must have a documented KRAS G12C mutation from an approved test.
  • Participants must have tried standard treatments available for their cancer and either did not respond, could not tolerate them, or the cancer returned after treatment.
  • For Part 2 of the study, participants must not have been treated with KRAS G12C inhibitors before (G12C inhibitors naive).
  • Participants must be at least 18 years old.
  • Both male and female participants are eligible.

Who cannot join the trial?

9 criteria

  • Patients with other types of cancer that are not part of the study, such as those without the specific KRAS G12C mutation.
  • Patients who have previously been treated with a KRAS G12C inhibitor, which is a type of medication targeting a specific mutation in cancer cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or comply with the study requirements.
  • Patients with certain medical conditions that might interfere with the study treatment or its evaluation.
  • Patients who are pregnant or breastfeeding, as the study treatment may affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients with a history of severe allergic reactions to any of the study medications.
  • Patients with uncontrolled medical conditions that could make it unsafe to participate in the study.
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Investigated drugs

  • BMS-986466

    is an experimental drug being tested to see if it can help treat certain types of cancer. In this study, it is being used to see if it can work together with other cancer treatments to stop or slow down the growth of tumors. The goal is to find out if this drug is safe for patients and to determine the best dose to use in future studies.

  • Adagrasib

    is a medication that targets a specific mutation in cancer cells known as KRAS G12C. This mutation is found in some types of advanced cancers, such as lung and colorectal cancer. Adagrasib works by blocking the signals that tell cancer cells to grow and divide, which may help to slow down or stop the progression of the disease.

  • Cetuximab

    is a type of therapy known as a monoclonal antibody. It is used to treat certain types of cancer by targeting a protein on the surface of cancer cells. This protein is involved in the growth and spread of cancer cells. By blocking this protein, cetuximab can help to slow down or stop the growth of tumors. In this study, it is being used in combination with other treatments to see if it can improve their effectiveness against cancer.

What is already known about the treatment

  • BMS-986466

    BMS-986466 is administered orally and is currently being studied in clinical trials for its potential use in treating certain types of cancer, specifically advanced solid tumors with a KRAS G12C mutation. This medication is being evaluated for its safety and effectiveness when used in combination with other drugs like adagrasib and cetuximab. It works by targeting specific molecular pathways involved in cancer cell growth, aiming to inhibit the activity of the KRAS G12C mutation, which is known to drive cancer progression. BMS-986466 falls under the category of targeted cancer therapies, which are designed to interfere with specific molecules involved in tumor growth and survival.

  • Adagrasib

    Adagrasib is an oral medication currently under investigation for its role in treating cancers with the KRAS G12C mutation, such as non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). It is being tested both alone and in combination with other drugs like BMS-986466 and cetuximab to assess its safety and effectiveness. Adagrasib works by specifically inhibiting the KRAS G12C protein, which is a key driver of cancer cell growth in these tumors. It is classified as a targeted therapy, focusing on blocking the molecular mechanisms that allow cancer cells to proliferate.

  • Cetuximab

    Cetuximab is administered intravenously and is a well-established medication used in the treatment of certain types of cancer, including colorectal cancer. In the context of the current clinical trial, it is being combined with BMS-986466 and adagrasib to explore its potential benefits in treating KRAS G12C-mutant cancers. Cetuximab works by targeting the epidermal growth factor receptor (EGFR) on the surface of cancer cells, which can help slow down or stop their growth. It is classified as a monoclonal antibody, a type of targeted therapy that specifically binds to proteins on cancer cells to inhibit their function.

Investigated diseases

  • Non-Small Cell Lung Cancer (NSCLC)

    Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs. As the disease advances, it can metastasize to distant parts of the body, affecting overall health and organ function. The progression rate can vary depending on the subtype and individual patient factors.

  • Colorectal Cancer (CRC)

    Colorectal Cancer is a type of cancer that starts in the colon or rectum, parts of the large intestine. It often begins as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can grow into the wall of the colon or rectum and spread to nearby lymph nodes and other organs. The progression involves the growth of tumors that can obstruct the bowel and cause various symptoms. Advanced stages may involve metastasis to distant organs such as the liver or lungs. The rate of progression can vary based on genetic factors and the cancer's location within the colon or rectum.

  • Pancreatic Ductal Adenocarcinoma (PDAC)

    Pancreatic Ductal Adenocarcinoma is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It typically progresses rapidly, with cancer cells forming tumors that can block the bile duct and cause jaundice. As the disease advances, it can invade nearby organs such as the stomach and intestines. The cancer may also spread to distant organs, including the liver and lungs. Tumor growth can lead to symptoms like abdominal pain and weight loss. The progression is often aggressive, impacting the function of the pancreas and other affected organs.

  • Biliary Tract Cancer (BTC)

    Biliary Tract Cancer refers to cancers that occur in the bile ducts, gallbladder, or ampulla of Vater. It often begins in the cells lining the bile ducts and can obstruct the flow of bile, leading to jaundice. As the disease progresses, tumors can grow and invade nearby tissues and organs, such as the liver and pancreas. The cancer may spread to distant parts of the body, affecting overall health. Symptoms can include abdominal pain, weight loss, and changes in liver function. The progression can vary depending on the cancer's location and the patient's overall health.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505070-15-00Protocol codeCA126-0015Estimated enrolment399 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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