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A Study of BMS-986517 for Adults with Advanced Solid Tumors to Test Safety and Find the Best Dose

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 looking at people with advanced solid tumors, which are cancers that have grown or spread in the body and cannot be removed by surgery. The specific types of cancer being studied include lung cancer, head and neck cancer, triple-negative breast cancer, and a certain type of hormone receptor-positive breast cancer. The treatment being tested is BMS-986517, which is given as a solution for infusion directly into a vein. This medication is being studied on its own, without being combined with other treatments.

The purpose of the study is to find out what doses of BMS-986517 are safe and how much people can tolerate in order to choose the best dose for future use, and to check if giving BMS-986517 at the chosen dose continues to be safe for people with specific cancers. The study will also monitor how often side effects occur, including serious side effects and those that might require stopping treatment. Additionally, the study will track whether tumors shrink and how long any responses last, as well as how the medication moves through and is processed by the body.

The study is divided into two parts. The first part focuses on testing different doses to determine which are safe and well tolerated. The second part uses the doses chosen from the first part to further evaluate safety in people with specific types of cancer. Participants will receive the medication through infusion and will be monitored for side effects during the first 21 days and throughout the treatment period, which can last up to 3 years from the first treatment, with additional monitoring for 30 days after the last treatment.

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

    Receiving the study medication

    You will receive BMS-986517 as the treatment in this study.

    The medication will be given to you through a vein, which is called intravenous infusion.

    The medication comes in the form of a solution for infusion, which means it is a liquid that will be slowly delivered into your bloodstream.

  2. Step 2

    Initial monitoring period

    During the first 21 days after receiving your first dose, you will be closely monitored for any side effects.

    This period is particularly important because doctors need to observe whether you experience any serious side effects called Dose Limiting Toxicities, which are specific reactions that help determine if the dose is safe.

    The doctors will track all side effects, serious side effects, and any reactions that might require stopping the treatment.

  3. Step 3

    Ongoing treatment and monitoring

    You will continue receiving BMS-986517 as a single treatment, which means it is not combined with other cancer medications.

    The study involves two parts. Part 1 focuses on finding safe doses and how much people can tolerate. Part 2 checks if the chosen dose continues to be safe for people with specific types of cancer.

    Your doctors will regularly check how your body processes the medication and how it moves through your system. This monitoring will continue up to 30 days after your last treatment.

  4. Step 4

    Tumor response assessment

    Throughout the study, your doctors will assess whether your tumors are shrinking in response to the treatment.

    These assessments will be conducted by your study doctors and will continue for up to 3 years from when you receive your first treatment.

    The doctors will also monitor how long any positive responses to the treatment last.

  5. Step 5

    Final monitoring period

    After you receive your last dose of BMS-986517, you will continue to be monitored for 30 days.

    During this time, doctors will track any side effects, serious side effects, or other health changes that may occur.

    This follow-up period ensures your safety after completing the treatment.

Who can join the trial?

6 criteria

  • You must be at least 18 years old or older when you sign the informed consent form, which is a document that explains the study and confirms you agree to take part
  • You must have at least one measurable lesion, which is a tumor or cancer growth that can be seen and measured on scans
  • You must be in good overall health and able to carry out most of your regular daily tasks
  • You must have advanced cancer, which means cancer that cannot be removed by surgery or has spread to other parts of the body
  • The types of cancer that qualify include lung cancer, head and neck cancer, triple-negative breast cancer (a type of breast cancer that does not have certain receptors), and a certain kind of hormone receptor-positive breast cancer (a type of breast cancer that grows in response to hormones)
  • You must have already received treatment for your advanced cancer before joining this study

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation
  • Exclusion criteria typically include things like other medical conditions, previous treatments, laboratory test results, or medications that might make it unsafe for someone to join the study
  • The study involves testing a medication called BMS-986517 in people with advanced solid tumors, which are cancers that have grown and spread in organs or tissues of the body
  • The study accepts both male and female participants who are adults
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Investigated drugs

BMS-986517 is an investigational medication being studied as a treatment for advanced solid tumors, which are cancerous growths that can occur in various parts of the body. This is the first time this medication is being tested in humans. The purpose of this study is to find out what doses are safe and well-tolerated, and to evaluate whether it works in treating specific types of cancer. Participants will receive this medication on its own, without combination with other cancer treatments.

What is already known about the treatment

BMS-986517 – BMS-986517 is an experimental cancer medication currently being studied in early-phase clinical trials for the treatment of advanced solid tumors. It is being tested as a single-agent therapy given to adult patients whose cancer has progressed or spread. The study is examining what doses are safe for patients to take and how well people tolerate the medication, while also evaluating its effectiveness in treating specific types of cancer. As this is a first-in-human trial, the medication is still in the early stages of research and is not yet approved for general medical use.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to cancerous growths that have developed from solid tissues, such as organs or connective tissues, and have progressed to a more severe stage. These tumors are typically characterized by their spread beyond the original site where they first formed. The cancer cells form masses or lumps that can grow larger over time and may spread to nearby tissues or distant parts of the body. As the disease advances, the tumors become more difficult to manage and may affect the function of surrounding organs and structures. The progression involves the continuous growth of cancer cells that divide and multiply in an uncontrolled manner. Advanced stages indicate that the cancer has grown significantly or has spread to other areas of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-522203-23-00Protocol codeCA2540001Estimated enrolment58 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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