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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Rigshospitalet Copenhagen Denmark
Hospital Universitario Virgen De La Victoria Malaga Spain
Hddixjrb Vklc dmzkipwm Barcelona Spain
Hzdzxt Hveyhuti Herlev Denmark
Iffnlbaw Cxufic Ddvhegkfcriabnuqs L'hospitalet De Llobregat Spain

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.01.2026
Spain Spain
Recruiting
01.01.2026

Trial locations

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.

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 ID:
2025-522203-23-00
Protocol code:
CA2540001
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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