A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

NCT07160725 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA254-0001EU CTRWHO
• Study Type: interventional
• Target: 315
• Locations: 4 countries
• Sites: 19

Brief Summary

A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Adverse Events (AE)

  Up to approximately 2 years

• Number of Participants with Serious Adverse Events (SAE)

  Up to approximately 2 years

• Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria

  For part 1 only

  Up to Day 21

• Number of Participants with AEs Leading to Discontinuation

  Up to approximately 2 years

• Number of Participants with AEs Leading to Deaths

  Up to approximately 2 years

Secondary Outcomes (6)

• Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment

  Up to approximately 3 years

• Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment

  Up to approximately 3 years

• Maximum Plasma Concentration (Cmax)

  Up to approximately 2 years

• Time to Reach Maximum Plasma Concentration (Tmax)

  Up to approximately 2 years

• Area Under Curve (AUC)

  Up to approximately 2 years

Study Arms (4)

Part 1

EXPERIMENTAL

Drug: BMS-986517

Part 2: Cohort A

EXPERIMENTAL

Drug: BMS-986517

Part 2: Cohort B

EXPERIMENTAL

Drug: BMS-986517

Part 2: Cohort C

EXPERIMENTAL

Drug: BMS-986517

Interventions

BMS-986517 DRUG

Specified dose on specified days

Part 1; Part 2: Cohort A; Part 2: Cohort B; Part 2: Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (19)

Local Institution - 0033

Irvine, California, 92612, United States

NOT YET RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Local Institution - 0021

Orange, California, 92868, United States

NOT YET RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

RECRUITING

START - Dallas Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Herlev and Gentofte Hospital

Copenhagen, Capital Region, 2730, Denmark

RECRUITING

Odense Universitetshospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Local Institution - 0026

Málaga, Andalusia, 29010, Spain

NOT YET RECRUITING

Local Institution - 0022

Badalona, Barcelona [Barcelona], 08916, Spain

NOT YET RECRUITING

Local Institution - 0024

Barcelona, Barcelona [Barcelona], 08035, Spain

NOT YET RECRUITING

Local Institution - 0025

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Local Institution - 0027

Madrid, 28040, Spain

NOT YET RECRUITING

Local Institution - 0023

Madrid, 28050, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (9); ES (6); JP (1); DK (3)