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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hopital Cardiologique Lille France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
CHU Bordeauxt Bordeaux France
Iynvky Ibabwknw Fmqquempjutix Onubgwockts Rome Italy
Ivfrxkds Csnhsl Dcoerwmqiskogpgnk L'hospitalet De Llobregat Spain
Ciywotdkd Upermkbbohowjd Slajxwjdx Woluwe-Saint-Lambert Belgium
Amcraezzmg Pqtnzgmn Hahricmf Dd Muuxcvlce Marseille France
Hltqblmj Uaxucvwdvu Chajuzw Honangpm Helsinki Finland
Hcnkhwtp Vjou datvcxkk Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.01.2024
Finland Finland
Not recruiting
01.01.2024
France France
Not recruiting
01.01.2024
Italy Italy
Not recruiting
01.01.2024
Spain Spain
Not recruiting
01.01.2024

Trial locations

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.

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 ID:
2023-505070-15-00
Protocol code:
CA126-0015
NCT ID:
NCT06024174
Trial Phase:
Human Pharmacology (Phase I) – Other

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