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A study to evaluate the safety and effectiveness of BMS-986523 alone or in combination with a drug combination for patients with advanced solid tumors and KRAS alterations.

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is being conducted to evaluate the safety and effectiveness of the drug BMS-986523 in patients with Advanced Solid Tumor Malignancies, which are types of cancer that have formed masses in the body and have spread. The research focuses on cases where there are KRAS alterations, which are specific changes or mutations in the genes that help control cell growth. The study will look at how the drug works when used alone or when combined with other treatments such as pembrolizumab, cetuximab, or gemcitabine and nab-paclitaxel.

Participants in the study may receive the experimental medication as a single treatment or alongside other anti-cancer agents. During the trial, researchers will monitor how the body processes the medicine and how the drug moves through the bloodstream. The investigation aims to determine the most effective dose and schedule for the treatment while watching for any side effects that may occur.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    The trial involves taking the test medication, BMS-986523, which is provided in the form of a film-coated tablet to be taken by mouth.

    The medication may be administered as a monotherapy, which means it is taken alone, or in combination with other anti-cancer medicines, such as pembrolizumab, cetuximab, or a mixture of gemcitabine and nab-paclitaxel.

  2. Step 2

    Safety and dose monitoring

    During the treatment, the frequency of side effects is monitored to ensure the medication is safe and can be tolerated by the body.

    The dose, or the amount of medicine taken, and the schedule, or the timing of the doses, are evaluated to determine the most effective way to use the medication.

  3. Step 3

    Medical evaluations

    blood tests are performed to track how the medication moves through and is processed by the body, including measuring the highest level of the drug in the blood and how long it takes to reach that level.

    The effectiveness of the treatment is assessed by measuring the overall response rate, which refers to how much the tumors shrink or change, using standardized medical measurements.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of a solid tumor, which is a type of cancer that forms a lump or mass in the body, that is either locally advanced (has spread within the area where it started) or metastatic (has spread to other parts of the body).
  • The cancer must be unresectable, meaning it cannot be removed by surgery.
  • Your cancer must have a known KRAS alteration, which means there is a specific change or error in the KRAS gene (a part of your DNA that helps control how cells grow).
  • Depending on the specific part of the study you are assigned to, the cancer type may be limited to NSCLC (a type of lung cancer), CRC (colon cancer), or PDAC (a type of pancreatic cancer).
  • You must have already received certain standard of care treatments (the usual treatments doctors provide for your condition), or you must be unable to take them, or you must have chosen not to take them after being fully informed about the options.
  • The study is open to both males and females.
  • You must fall within the specific age range required for this study.

Who cannot join the trial?

3 criteria

  • You cannot join if you have untreated central nervous system (CNS) metastases, which means cancer that has spread to the brain or spinal cord and has not yet been treated.
  • You cannot participate if you have another type of cancer that needs treatment right now, or if you have had cancer that was active within the last 2 years.
  • You cannot join if you have previously taken any (K)RAS directed therapy, which refers to medicines specifically designed to target a certain type of genetic change in cancer cells.
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Investigated drugs

BMS-986523 is an experimental medicine being tested to see if it is safe and effective for treating advanced types of solid cancer. In this study, it may be given by itself or used together with other cancer treatments.

What is already known about the treatment

BMS-986523 - This medication is taken as a pill that is swallowed by mouth and is currently being studied in clinical trials for its potential to treat advanced solid tumors. It belongs to a class of drugs known as KRAS inhibitors, which are designed to target specific genetic changes in cancer cells. At a molecular level, the drug works by blocking a protein called KRAS that acts like a faulty switch, constantly signaling cancer cells to grow and divide. By turning off this signal, the medication aims to stop the spread and growth of the tumor.

Investigated diseases

Advanced solid tumor malignancies - These are types of cancer that form in organs or tissues rather than in the blood or bone marrow. These tumors develop from abnormal cell growth that has spread or become more extensive within the body. The disease involves cells that have acquired specific genetic changes, such as alterations in the KRAS gene. As the condition progresses, the cancerous cells multiply and can expand into surrounding healthy tissues. The tumors can also move from their original location to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-523547-35-00Protocol codeCA2560001Estimated enrolment252 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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