Recruiting

BMS-986517 for Advanced Solid Tumors

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

BMS-986517

Drug
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2025

Actual 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 
NCT07160725
Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: December 11, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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 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).
Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
Participants must not have history of serious recurrent infections.
Participants must not have impaired cardiac function or history of severe heart disease.
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

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

Sanford Cancer Center

Sioux Falls, United StatesSee the location
Recruiting

START - Dallas Fort Worth

Fort Worth, United States
Recruiting

START San Antonio

San Antonio, United States
Recruiting

START Mountain Region

West Valley City, United States
Recruiting
18 Study Centers