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

NCT ID: NCT07160725

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2028-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Solid Tumours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

BMS-986517

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort A

Group Type EXPERIMENTAL

BMS-986517

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort B

Group Type EXPERIMENTAL

BMS-986517

Intervention Type DRUG

Specified dose on specified days

Part 2: Cohort C

Group Type EXPERIMENTAL

BMS-986517

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986517

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0033

Irvine, California, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0002

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0021

Orange, California, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0008

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Site Status RECRUITING

START - Dallas Fort Worth

Fort Worth, Texas, United States

Site Status RECRUITING

START San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

START Mountain Region

West Valley City, Utah, United States

Site Status RECRUITING

Local Institution - 0028

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Herlev and Gentofte Hospital

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Site Status RECRUITING

Copenhagen University Hospital Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Local Institution - 0026

Málaga, Andalusia, Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0022

Badalona, Barcelona [Barcelona], Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0024

Barcelona, Barcelona [Barcelona], Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0025

Pamplona, Navarre, Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0027

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0023

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Denmark Japan Spain

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

8559073286

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

Role: CONTACT

Facility Contacts

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Site 0033

Role: primary

Site 0002

Role: primary

Site 0021

Role: primary

Site 0008

Role: primary

Steven Powell, Site 0005

Role: primary

605-328-8000

Henry Xiong, Site 0030

Role: primary

682-350-3010

Drew Rasco, Site 0020

Role: primary

210-593-5250

William McKean, Site 0031

Role: primary

801-907-4750

Site 0028

Role: primary

Mogens Boisen, Site 0016

Role: primary

+45 38 68 91 25

Annette Kodahl, Site 0015

Role: primary

+45 21133379

Kristoffer Rohrberg, Site 0017

Role: primary

+ 45 3545 9540

Noboru Yamamoto, Site 0029

Role: primary

81335422511

Site 0026

Role: primary

Site 0022

Role: primary

Site 0024

Role: primary

Site 0025

Role: primary

Site 0027

Role: primary

Site 0023

Role: primary

Related Links

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Other Identifiers

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EU CTR

Identifier Type: OTHER

Identifier Source: secondary_id

WHO

Identifier Type: OTHER

Identifier Source: secondary_id

CA254-0001

Identifier Type: -

Identifier Source: org_study_id

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