Recruiting

BMS-986517 for Advanced Solid Tumors

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What is being tested

BMS-986517

Drug
Who is being recruted

Solid Tumours

Over 18 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 15, 2025Actual date on which the first participant was enrolled.

This clinical study is exploring a new treatment called BMS-986517 for adults who have advanced solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas and can occur in any part of the body. The main goal of this study is to determine if BMS-986517 is safe and well-tolerated when used by itself in people with these types of tumors. Understanding the safety of this new treatment can help researchers develop more effective therapies for cancer patients, potentially improving their quality of life and treatment outcomes. In this study, participants receive BMS-986517 as a standalone treatment. The study is open-label, meaning both the researchers and participants know what treatment is being given. The primary focus is to observe how well participants tolerate the treatment and to monitor any side effects they might experience. This initial phase of the study does not have specific primary outcomes listed, but it generally looks to gather information on the safety profile of the treatment, which is crucial for determining if it can be considered for further testing in more advanced trials.

Official TitleA Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors 
Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
315 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Solid Tumours
Criteria
3 inclusion criteria required to participate
Participants must have an ECOG performance status of 0 to 1.
Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
5 exclusion criteria prevent from participating
Participants must not have history of serious recurrent infections.
Participants must not have impaired cardiac function or history of severe heart disease.
Other protocol-defined inclusion/exclusion criteria apply.
Participants must not have untreated CNS metastases. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Group II
Experimental
Group III
Experimental
Group IV
Experimental
Study Objectives
Primary Objectives

For part 1 only

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 18 locations
Recruiting
START San AntonioSan Antonio, United StatesSee the location
Recruiting soon
Local Institution - 0002Los Angeles, United States
Recruiting soon
Local Institution - 0021Orange, United States
Recruiting soon
Local Institution - 0008Pittsburgh, United States
Recruiting
18 Study Centers