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Long‑term Safety of Adagrasib with Drug Combination in Adults with Solid Tumors

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What is this trial about?

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

The study focuses on patients with a solid tumor, which is a lump of abnormal cells that can grow in any organ or tissue. The investigational medicine is Adagrasib (BMS-986503), which may be given alone or together with other cancer therapies such as pemetrexed, cetuximab and pembrolizumab. Standard supportive drugs that are also used in the study include dexamethasone, taken by mouth, and palonosetron, given through a vein to help prevent nausea.

The main aim of the trial is to assess the long‑term safety of the study drug, meaning how well it is tolerated over time and what side effects may occur. Participants who have already finished earlier studies receive the medication for an extended period, attending regular visits where health checks, blood tests and simple scans are performed. Any unwanted problems, called adverse events, are recorded and evaluated, with particular attention to serious issues that might require medical care.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First study visit (baseline)

    You will meet the study staff, give informed consent, and undergo baseline assessments such as blood tests, imaging, and a review of your medical history.

    The purpose of these assessments is to document your condition before any study medication is started.

  2. Step 2

    Start oral <b>adagrasib</b>

    You will begin taking adagrasib, a film‑coated tablet taken by mouth, at a dose of 9999 mg per day. the exact schedule (for example, once daily) will be provided by the study team.

    The tablet is intended to be swallowed with water and should be taken at the same time each day.

  3. Step 3

    Background medication <b>dexamethasone</b>

    In addition to adagrasib, you will receive dexamethasone, an oral steroid, at a dose of 9999 mg. this medication helps reduce inflammation and may lessen certain side effects.

  4. Step 4

    Intravenous combination therapy (if assigned)

    If your treatment plan includes additional cancer medicines, you will receive them by intravenous (iv) infusion, which means the drug is given through a needle into a vein.

    The iv medicines may include pemetrexed (dose 9999 mg/ml), cetuximab (dose 9999 mg/m2), and pembrolizumab (dose 9999 mg/ml). each will be given on the days scheduled by the study team.

    To help prevent nausea, you will also receive palonosetron by iv at a dose of 9999 µg/ml.

  5. Step 5

    Regular safety visits

    You will return to the clinic regularly (for example, every 4 weeks) for physical examinations, blood tests, and to discuss any side effects you have experienced.

    The study staff will record any adverse events, which are any unwanted medical occurrences, whether or not they are related to the study medication.

  6. Step 6

    Continuation of treatment

    You will continue taking the oral medication and receiving any iv medications as long as you remain in the study, up to the planned end date of february 28, 2028, unless a serious side effect requires stopping the treatment.

  7. Step 7

    Final study visit

    At the end of the study, you will have a final assessment that includes a physical exam, laboratory tests, and a summary of any side effects that occurred during the study.

    The results of these assessments will be used to evaluate the long‑term safety of adagrasib alone or in combination with the other cancer therapies.

Who can join the trial?

4 criteria

  • Must be older than 18 years at the time they sign the consent form.
  • Must sign and date an informed consent document that has been approved by an IRB/IEC (an independent committee that reviews research to protect participants), and be willing and able to attend scheduled visits, follow the treatment schedule, and have any required lab tests.
  • Must be eligible to continue receiving the study medication according to the rules of the original (parent) study.
  • Must not be able to become pregnant, or if they could become pregnant they must have a negative pregnancy test during the study and use effective contraception (reliable birth‑control methods) throughout the study.

Who cannot join the trial?

4 criteria

  • If you are not allowed to receive the study medication according to the rules of the earlier related study (parent study), you cannot take part.
  • If you have already finished taking the study drug, if your disease got worse while on a previous study treatment, or if you stopped a previous study treatment because of harmful side effects (toxicity), you cannot join.
  • If you are not experiencing any health improvement (clinical benefit) from the earlier study, or if you have side effects (adverse events (AE)) or unusual test results (lab abnormality) that the doctor believes make participation unsafe, you cannot join.
  • If you have an allergy or a strong allergic reaction (hypersensitivity) to any part of the study drug, you cannot take part.
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Investigated drugs

  • DEXAMETHASONE

    is a steroid medication that helps reduce inflammation and swelling. In this study it is given to participants as part of the standard supportive care to help manage side effects from other cancer treatments.

  • PEMETREXED

    is a chemotherapy drug that works by stopping cancer cells from making DNA, which they need to grow and divide. In the trial it is used as one of the experimental treatments being tested together with other medicines.

  • Adagrasib

    is a targeted therapy that blocks a specific mutation (KRAS G12C) found in some cancers. The study is looking at how safe it is when taken alone or combined with other cancer medicines.

  • CETUXIMAB

    is a monoclonal antibody that attaches to a protein called EGFR on the surface of cancer cells. By blocking this protein, it can slow down or stop the growth of the tumor. It is being tested as part of the experimental treatment regimen.

  • PALONOSETRON

    is a medication used to prevent nausea and vomiting that often occur with chemotherapy. In this trial it is given to help keep participants comfortable during treatment.

  • PEMBROLIZUMAB

    is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a checkpoint that normally keeps the immune response in check, and it is being evaluated as one of the test therapies in the study.

What is already known about the treatment

  • DEXAMETHASONE

    This medication is taken by mouth as a tablet. It is an established corticosteroid that is widely used in medical practice to reduce inflammation and suppress the immune response, and it also helps prevent nausea from chemotherapy. Dexamethasone works by binding to glucocorticoid receptors and changing the activity of many genes that control inflammation. It belongs to the drug class called glucocorticoids.

  • PEMETREXED

    Pemetrexed is given by intravenous infusion into a vein. It is an approved chemotherapy drug mainly used for treating certain types of lung cancer and other solid tumors. The drug interferes with the building blocks of DNA, stopping cancer cells from making new DNA and dividing. It is classified as an antifolate antimetabolite.

  • Adagrasib

    Adagrasib is taken as an oral film‑coated tablet. It is currently being studied in clinical trials for solid tumors that have a KRAS G12C mutation and is not yet an approved medicine. The molecule binds specifically to the mutant KRAS protein and locks it in an inactive form, which blocks signals that tell cancer cells to grow. It is a targeted therapy and is classified as a small‑molecule KRAS inhibitor.

  • CETUXIMAB

    Cetuximab is administered by intravenous infusion. It is an approved treatment for colorectal cancer and head‑and‑neck cancers, where it is used to slow tumor growth. The drug is a monoclonal antibody that attaches to the epidermal growth factor receptor (EGFR) on cancer cells, preventing the receptor from sending growth signals. It belongs to the class of EGFR‑targeting biologic agents.

  • PALONOSETRON

    Palonosetron is given by intravenous injection. It is an approved anti‑nausea medication used to prevent vomiting and nausea caused by chemotherapy. The drug blocks a chemical messenger called serotonin at the 5‑HT3 receptor, which stops the signal that triggers nausea. It is classified as a serotonin 5‑HT3 receptor antagonist, an antiemetic.

  • PEMBROLIZUMAB

    Pembrolizumab is delivered through an intravenous infusion. It is an approved immunotherapy for many solid tumors, helping the body’s own immune system recognize and attack cancer cells. The antibody binds to the PD‑1 protein on immune cells, blocking the “off” signal that tumors use to hide from the immune system. It is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Solid tumor - A solid tumor is a lump of abnormal cells that forms in organs or tissues such as the lung, breast, colon, or bone. It grows by dividing and accumulating more cells, which can enlarge the mass over time. As the tumor expands, it may push against surrounding structures, causing changes in organ function. Cancer cells from the tumor can break away and travel through the bloodstream or lymphatic system to create new growths in other parts of the body. This spread, called metastasis, leads to additional sites of disease that grow in a similar manner.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524905-34-00Protocol codeCA239-0071Estimated enrolment204 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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