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NCT06618287PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

2/4/2025

Completion Date

2/26/2031

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * 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. Exclusion Criteria * 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.

Interventions

DRUG

BMS-986507

DRUG

Osimertinib

DRUG

Pembrolizumab

DRUG

Nivolumab

DRUG

Pumitamig

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Conditions

Lung CancerBreast Cancer

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida 33136

United States

Local Institution - 0065

Iowa City, Iowa 52242

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Local Institution - 0102

Columbus, Ohio 43212

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence St. Vincent Medical Center

Portland, Oregon 97225

United States

Local Institution - 0052

Portland, Oregon 97239

United States

Local Institution - 0014

Pittsburgh, Pennsylvania 15232

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

NEXT Oncology - Irving

Irving, Texas 75039

United States

Swedish Medical Center

Seattle, Washington 98104

United States

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

Local Institution - 0101

Subiaco, Western Australia 6008

Australia

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

Local Institution - 0064

Newmarket, Ontario L3Y 2P9

Canada

Local Institution - 0023

Ottawa, Ontario K1H 8L6

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Local Institution - 0105

Valdivia, Los Ríos Region 5112129

Chile

Local Institution - 0048

Santiago, Santiago Metropolitan 7500921

Chile

Local Institution - 0049

Santiago, Santiago Metropolitan 8330032

Chile

Local Institution - 0047

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0107

Viña del Mar, Valparaiso 2520598

Chile

Local Institution - 0077

Nice, Alpes-Maritimes 06189

France

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine 33076

France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes 69008

France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône 13385

France

Local Institution - 0076

Caen, Calvados 14076

France

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault 34090

France

Gustave Roussy

Villejuif, Val-de-Marne 94800

France

Institut Curie

Paris, 75248

France

Hôpital Tenon

Paris, 75970

France

Cro-Irccs

Aviano, Friuli Venezia Giulia 33081

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy 20133

Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino 10060

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany 50134

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, 00168

Italy

Leids Universitair Medisch Centrum

Leiden, South Holland 2333 ZA

Netherlands

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

Amsterdam, 1066 CX

Netherlands

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Barcelona [Barcelona] 08907

Spain

Local Institution - 0059

Barcelona, Catalunya [Cataluña] 08036

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de 28222

Spain

Local Institution - 0118

Valencia, Valenciana, Comunitat 46010

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Local Institution - 0127

Madrid, 28040

Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

H.R.U Málaga - Hospital General

Málaga, 29011

Spain

Local Institution - 0112

Seville, 41009

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Royal Free Hospital

London, England NW32QG

United Kingdom

Local Institution - 0021

Glasgow, Glasgow City G12 0YN

United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands B15 2GW

United Kingdom

Local Institution - 0001

Newcastle upon Tyne, NE7 7DN

United Kingdom