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

September 11, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

416

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Abhijit Pal, Site 0027
          • Phone Number: 61287389744
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Wen Xu, Site 0028
          • Phone Number: +61731766577
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Peter Savas, Site 0108
          • Phone Number: +61402147682
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Quincy Chu, Site 0024
          • Phone Number: 7804328248
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
          • Scott Laurie, Site 0026
          • Phone Number: 6137377700
      • Ottawa, Ontario, Canada, K1H 8L6
        • Withdrawn
        • Local Institution - 0023
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Jennifer Friedmann, Site 0025
          • Phone Number: 514340822224915
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
          • Marie Florescu, Site 0022
          • Phone Number: 5148908000
      • Montreal, Quebec, Canada, H4A3J1
        • Not yet recruiting
        • Local Institution - 0144
        • Contact:
          • Site 0144
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia
        • Contact:
          • Maria Herrera, Site 0105
          • Phone Number: +56992195434
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Carlos Rojas, Site 0047
          • Phone Number: +56998744662
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Recruiting
        • FALP
        • Contact:
          • Christian Caglevic, Site 0048
          • Phone Number: 56224457254
      • Santiago, Santiago Metropolitan, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Católica de Chile
        • Contact:
          • Benjamin Walbaum, Site 0049
          • Phone Number: 56976223722
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • Oncocentro Apys
        • Contact:
          • Alejandro Acevedo Gaete, Site 0107
          • Phone Number: +56992369820
  • France
      • Paris, France, 75248
        • Recruiting
        • Institut Curie
        • Contact:
          • nicolas girard, Site 0054
          • Phone Number: +33624456290
      • Paris, France, 75970
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Jacques Cadranel, Site 0040
          • Phone Number: 33156016531
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Withdrawn
        • Local Institution - 0077
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Contact:
          • Sophie Cousin, Site 0043
          • Phone Number: 33556333229
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Recruiting
        • Centre Léon Bérard
        • Contact:
          • Aurelie Swalduz, Site 0050
          • Phone Number: +33469856041
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
        • Contact:
          • Laurent Greillier, Site 0045
          • Phone Number: 33491324400
    • Calvados
      • Caen, Calvados, France, 14076
        • Withdrawn
        • Local Institution - 0076
    • Hérault
      • Montpellier, Hérault, France, 34090
        • Recruiting
        • Hôpital Arnaud de Villeneuve - CHU Montpellier
        • Contact:
          • Benoit Roch, Site 0053
          • Phone Number: +33467330759
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • David Planchard, Site 0041
          • Phone Number: 33142114211
  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Contact:
          • Gennaro Daniele, Site 0032
          • Phone Number: +390630153446
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • Cro-Irccs
        • Contact:
          • Alessandra Bearz, Site 0034
          • Phone Number: 390434659294
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Giuseppe Lo Russo, Site 0033
          • Phone Number: 390223903829
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
        • Contact:
          • Vanesa Gregorc, Site 0056
          • Phone Number: 390119933250
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
          • Lorenzo Antonuzzo, Site 0035
          • Phone Number: 00390557947298
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
        • Contact:
          • Gerrina Ruiter, Site 0003
          • Phone Number: 0031205122958
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Contact:
          • Egbert Smit, Site 0004
          • Phone Number: 31715262950
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
          • Ester García Lorenzo, Site 0017
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
          • Ramon Yarza Barrio, Site 0019
          • Phone Number: 349155048002805
      • Madrid, Spain, 28040
        • Withdrawn
        • Local Institution - 0127
      • Málaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General
        • Contact:
          • Manuel Cobo-Dols, Site 0063
          • Phone Number: 00349422033350000
      • Seville, Spain, 41009
        • Withdrawn
        • Local Institution - 0112
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Oscar Juan Vidal, Site 0060
          • Phone Number: 34961245877
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario
        • Contact:
          • Jorge Garcia Gonzalez, Site 0062
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Enriqueta Felip Font, Site 0016
          • Phone Number: 34932746077
      • Hospitalet, Barcelona [Barcelona], Spain, 08907
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
        • Contact:
          • NOELIA Vilarino Quintela, Site 0058
          • Phone Number: 34932275402
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Withdrawn
        • Local Institution - 0059
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Luis Paz-Ares Rodriguez, Site 0018
          • Phone Number: 0034913908922
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Mariano Provencio Pulla, Site 0061
          • Phone Number: 34911917759
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Withdrawn
        • Local Institution - 0118
  • Taiwan
      • Tainan, Taiwan, 70428
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
      • Taipei, Taiwan, 100225
        • Not yet recruiting
        • Local Institution - 0145
        • Contact:
          • Site 0145
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • England
      • London, England, United Kingdom, NW32QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
          • Alexa Childs, Site 0030
          • Phone Number: 442077040500
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
          • Gary Middleton, Site 0020
          • Phone Number: 441214158237
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Aakash Desai, Site 0066
          • Phone Number: 919-525-0054
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center
        • Contact:
          • Gilberto DE LIMA LOPES JUNIOR, Site 0009
          • Phone Number: 305-243-1086
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • Local Institution - 0065
        • Contact:
          • Site 0065
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Local Institution - 0140
        • Contact:
          • Site 0140
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0010
          • Phone Number: 551-996-5863
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Khaled Hassan, Site 0029
          • Phone Number: 734-615-2939
      • Columbus, Ohio, United States, 43212
        • Not yet recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
          • David Page, Site 0090
          • Phone Number: 503-215-5401
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
          • David Page, Site 0134
          • Phone Number: 503-215-5401
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Withdrawn
        • Local Institution - 0014
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:
          • Sarah Jenkins, Site 0103
          • Phone Number: 865-305-8780
    • Texas
      • Irving, Texas, United States, 75039
        • Recruiting
        • NEXT Oncology - Irving
        • Contact:
          • Michael Song, Site 0092
          • Phone Number: 210-580-9500
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Medical Center
        • Contact:
          • Siddhartha Devarakonda, Site 0012
          • Phone Number: 206-386-2457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: BMS-986507
Specified dose on specified days
Other Names:
  • Izalontamab brengitecan
  • Iza-bren
Drug: Osimertinib
Specified dose on specified days
Experimental: Group B
Drug: Pembrolizumab
Specified dose on specified days
Drug: BMS-986507
Specified dose on specified days
Other Names:
  • Izalontamab brengitecan
  • Iza-bren
Experimental: Group C
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986507
Specified dose on specified days
Other Names:
  • Izalontamab brengitecan
  • Iza-bren
Experimental: Group D
Drug: BMS-986507
Specified dose on specified days
Other Names:
  • Izalontamab brengitecan
  • Iza-bren
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Group E
Drug: BMS-986507
Specified dose on specified days
Other Names:
  • Izalontamab brengitecan
  • Iza-bren
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 3 years
Up to 3 years
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 3 years
Up to 3 years
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
Time Frame: Up to 3 years
Up to 3 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to 3 years
Up to 3 years
Number of participants with AEs leading to death
Time Frame: Up to 3 years
Up to 3 years
Number of DLTs that occur during the DLT evaluation period
Time Frame: Up to 3 weeks
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax)
Time Frame: Up to 3 years
Up to 3 years
Time of maximum observed concentration (Tmax)
Time Frame: Up to 3 years
Up to 3 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to 3 years
Up to 3 years
Area under the serum concentration-time curve within a dosing interval (AUC(TAU))
Time Frame: Up to 3 years
Up to 3 years
Objective response rate (ORR)
Time Frame: Up to 2 year
Up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

February 26, 2031

Study Completion (Estimated)

February 26, 2031

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA244-0001
  • 2024-514947-27 (Other Identifier: EU CTR)
  • U1111-1308-2752 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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