A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Lung Cancer, Breast Cancer

In brief

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Key facts

Study ID

NCT06618287

Run by

Bristol-Myers Squibb

People needed

416

Starts

2025-02-04

Expected to finish

2031-02-26

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have a life expectancy of at least 3 months at the time of the first dose.
• Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed
• Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.
• Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.
• Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen.
• Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

You may not qualify if…

• Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
• Participants with known mutations in EGFR will be excluded (Group A,B and E).
• Participants must not have a history of serious recurrent infections.
• Participants must not have a history of severe heart disease.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Gustave Roussy — Villejuif, Val-de-Marne, France (enrolling)
• Cro-Irccs — Aviano, Friuli Venezia Giulia, Italy (enrolling)
• Centre Leon Berard — Lyon, Auvergne-Rhône-Alpes, France (enrolling)
• Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier, Hérault, France (enrolling)
• Hôpital Tenon — Paris, France (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, Aquitaine, France (enrolling)
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille, Bouches-du-Rhône, France (enrolling)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
• Institut Curie — Paris, France (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (enrolling)
• Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• NEXT Oncology - Irving — Irving, Texas, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.