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

Last updated: March 16, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lung Cancer

Cancer

Breast Cancer

Treatment

Pumitamig

Osimertinib

Nivolumab

Clinical Study ID

NCT06618287
CA244-0001
2024-514947-27
U1111-1308-2752
  • Ages > 18
  • All Genders

Study 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

Inclusion

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

  1. 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.

Study Design

Total Participants: 416
Treatment Group(s): 5
Primary Treatment: Pumitamig
Phase: 1/2
Study Start date:
February 04, 2025
Estimated Completion Date:
February 26, 2031

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Local Institution - 0027

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Local Institution - 0028

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Local Institution - 0108

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Local Institution - 0108

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Local Institution - 0101

    Subiaco, Western Australia 6008
    Australia

    Site Not Available

  • Local Institution - 0101

    Subiaco 2060886, Western Australia 2058645 6008
    Australia

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Local Institution - 0024

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton 5946768, Alberta 5883102 T6G 1Z2
    Canada

    Site Not Available

  • Local Institution - 0064

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Local Institution - 0023

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0026

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Local Institution - 0064

    Newmarket 6087701, Ontario 6093943 L3Y 2P9
    Canada

    Site Not Available

  • Local Institution - 0023

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Local Institution - 0025

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Local Institution - 0022

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montreal 6077243, Quebec 6115047 H2X 3E4
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • Local Institution - 0105

    Valdivia, Los Ríos Region 5112129
    Chile

    Site Not Available

  • Local Institution - 0105

    Valdivia 3868707, Los Ríos Region 6693563 5112129
    Chile

    Site Not Available

  • Local Institution - 0107

    Viña del Mar, Región de Valparaíso 2520598
    Chile

    Site Not Available

  • Local Institution - 0107

    Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
    Chile

    Site Not Available

  • Local Institution - 0047

    Santiago, Santiago Metropolitan 8420383
    Chile

    Site Not Available

  • Local Institution - 0048

    Santiago, Santiago Metropolitan 7500921
    Chile

    Site Not Available

  • Local Institution - 0049

    Santiago, Santiago Metropolitan 8330032
    Chile

    Site Not Available

  • Local Institution - 0047

    Santiago 3871336, Santiago Metropolitan 3873544 8420383
    Chile

    Site Not Available

  • Local Institution - 0048

    Santiago 3871336, Santiago Metropolitan 3873544 7500921
    Chile

    Site Not Available

  • Local Institution - 0049

    Santiago 3871336, Santiago Metropolitan 3873544 8330032
    Chile

    Site Not Available

  • Local Institution - 0077

    Nice, Alpes-Maritimes 06189
    France

    Site Not Available

  • Local Institution - 0077

    Nice 2990440, Alpes-Maritimes 06189
    France

    Site Not Available

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

    Bordeaux, Aquitaine 33076
    France

    Active - Recruiting

  • Local Institution - 0043

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

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

    Bordeaux 3031582, Aquitaine 33076
    France

    Site Not Available

  • Local Institution - 0043

    Bordeaux 3031582, Aquitaine 33076
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes 69008
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon 2996944, Auvergne-Rhône-Alpes 11071625 69008
    France

    Site Not Available

  • Local Institution - 0050

    Lyon 2996944, Auvergne-Rhône-Alpes 11071625 69008
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône 13385
    France

    Active - Recruiting

  • Local Institution - 0045

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille 2995469, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0045

    Marseille 2995469, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0076

    Caen, Calvados 14076
    France

    Site Not Available

  • Local Institution - 0076

    Caen 3029241, Calvados 14076
    France

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault 34090
    France

    Active - Recruiting

  • Local Institution - 0053

    Montpellier, Hérault 34090
    France

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier 2992166, Hérault 34090
    France

    Site Not Available

  • Local Institution - 0053

    Montpellier 2992166, Hérault 34090
    France

    Site Not Available

  • Local Institution - 0050

    Lyon, Rhône-Alpes 69008
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Val-de-Marne 94800
    France

    Active - Recruiting

  • Local Institution - 0041

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Gustave Roussy

    Villejuif 2968705, Val-de-Marne 94800
    France

    Site Not Available

  • Local Institution - 0041

    Villejuif 2968705, Val-de-Marne 94800
    France

    Site Not Available

  • Hôpital Tenon

    Paris, 75970
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Local Institution - 0040

    Paris, 75970
    France

    Site Not Available

  • Local Institution - 0054

    Paris, 75248
    France

    Site Not Available

  • Hôpital Tenon

    Paris 2988507, 75970
    France

    Active - Recruiting

  • Institut Curie

    Paris 2988507, 75248
    France

    Site Not Available

  • Local Institution - 0040

    Paris 2988507, 75970
    France

    Site Not Available

  • Local Institution - 0054

    Paris 2988507, 75248
    France

    Site Not Available

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia 33081
    Italy

    Active - Recruiting

  • Cro-Irccs

    Aviano 3182635, Friuli Venezia Giulia 3176525 33081
    Italy

    Site Not Available

  • Local Institution - 0034

    Aviano 3182635, Friuli Venezia Giulia 3176525 33081
    Italy

    Site Not Available

  • Local Institution - 0034

    Aviano, Friuli-Venezia Giulia 33081
    Italy

    Site Not Available

  • Local Institution - 0033

    Milan, Lombardia 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy 20133
    Italy

    Active - Recruiting

  • Local Institution - 0033

    Milan 3173435, Lombardy 3174618 20133
    Italy

    Site Not Available

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

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Local Institution - 0056

    Candiolo, Torino 10060
    Italy

    Site Not Available

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

    Candiolo 3180861, Torino 10060
    Italy

    Site Not Available

  • Local Institution - 0056

    Candiolo 3180861, Torino 10060
    Italy

    Site Not Available

  • Local Institution - 0035

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany 50134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Site Not Available

  • Local Institution - 0035

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Site Not Available

  • Local Institution - 0110

    Ancona, 60126
    Italy

    Site Not Available

  • Local Institution - 0093

    Milan, 20141
    Italy

    Site Not Available

  • Local Institution - 0093

    Milan 6951411, 20141
    Italy

    Site Not Available

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

    Roma, 00168
    Italy

    Active - Recruiting

  • Local Institution - 0032

    Roma, 00168
    Italy

    Site Not Available

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

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Local Institution - 0032

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, South Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden 2751773, South Holland 2743698 2333 ZA
    Netherlands

    Site Not Available

  • Local Institution - 0004

    Leiden, Zuid-Holland 2333 ZA
    Netherlands

    Site Not Available

  • Local Institution - 0003

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

    Amsterdam 2759794, 1066 CX
    Netherlands

    Site Not Available

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [La Coruña] 15706
    Spain

    Active - Recruiting

  • Local Institution - 0062

    Santiago de Compostela, A Coruña [La Coruña] 15706
    Spain

    Site Not Available

  • Local Institution - 0062

    Santiago de Compostela 3109642, A Coruña [La Coruña] 15706
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0016

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Institut Català d'Oncologia - L'Hospitalet

    Hospitalet, Barcelona [Barcelona] 08907
    Spain

    Active - Recruiting

  • Local Institution - 0058

    Hospitalet, Barcelona [Barcelona] 08907
    Spain

    Site Not Available

  • Local Institution - 0059

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Local Institution - 0059

    Barcelona 3128760, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Local Institution - 0018

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Local Institution - 0061

    Majadahonda, Madrid, Comunidad De 28222
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de 28041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, Madrid, Comunidad de 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda 3117667, Madrid, Comunidad de 28222
    Spain

    Site Not Available

  • Local Institution - 0061

    Majadahonda 3117667, Madrid, Comunidad de 28222
    Spain

    Site Not Available

  • Local Institution - 0118

    Valencia, Valenciana, Comunitat 46010
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Local Institution - 0017

    Madrid, 28040
    Spain

    Site Not Available

  • Local Institution - 0019

    Madrid, 28050
    Spain

    Site Not Available

  • Local Institution - 0127

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital General

    Málaga, 29011
    Spain

    Active - Recruiting

  • Local Institution - 0063

    Málaga, 29011
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital General

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Local Institution - 0063

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Local Institution - 0112

    Seville, 41009
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Local Institution - 0060

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Local Institution - 0060

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0020

    Birmingham, England B15 2TH
    United Kingdom

    Site Not Available

  • Local Institution - 0030

    London, England NW32QG
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, England NW32QG
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London 2643743, England 6269131 NW32QG
    United Kingdom

    Site Not Available

  • Local Institution - 0021

    Glasgow, Glasgow City G12 0YN
    United Kingdom

    Site Not Available

  • Local Institution - 0021

    Glasgow 2648579, Glasgow City G12 0YN
    United Kingdom

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands B15 2GW
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham 2655603, West Midlands B15 2GW
    United Kingdom

    Site Not Available

  • Local Institution - 0001

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Local Institution - 0001

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Site Not Available

  • Local Institution - 0066

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3300
    United States

    Active - Recruiting

  • Local Institution - 0066

    Birmingham 4049979, Alabama 4829764 35294-3300
    United States

    Site Not Available

  • Local Institution - 0009

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Local Institution - 0125

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Local Institution - 0065

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Local Institution - 0065

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0010

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Local Institution - 0029

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0102

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Local Institution - 0102

    Columbus 4509177, Ohio 5165418 43212
    United States

    Site Not Available

  • Local Institution - 0052

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0090

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0052

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Local Institution - 0090

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Local Institution - 0014

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Local Institution - 0014

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Local Institution - 0103

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Local Institution - 0103

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • Local Institution - 0092

    Irving, Texas 75039
    United States

    Site Not Available

  • Local Institution - 0092

    Irving 4700168, Texas 4736286 75039
    United States

    Site Not Available

  • Local Institution - 0012

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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