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

NCT06618287 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA244-00012024-514947-27U1111-1308-2752
• Study Type: interventional
• Target: 416
• Locations: 9 countries
• Sites: 64

Brief 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.

Conditions

Lung Cancer; Breast Cancer

Keywords

Non-Small Cell Lung Cancer (NSCLC); Epidermal Growth Factor Receptor mutated (EGFRmt); Epidermal Growth Factor Receptor wild-type (EGFRwt); Triple-negative breast cancer (TNBC)

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events (AEs)

  Up to 3 years

• Number of participants with serious adverse events (SAEs)

  Up to 3 years

• Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera

  Up to 3 years

• Number of participants with AEs leading to discontinuation

  Up to 3 years

• Number of participants with AEs leading to death

  Up to 3 years

• Number of DLTs that occur during the DLT evaluation period

  Up to 3 weeks

Secondary Outcomes (5)

• Maximum observed serum concentration (Cmax)

  Up to 3 years

• Time of maximum observed concentration (Tmax)

  Up to 3 years

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to 3 years

• Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

  Up to 3 years

• Objective response rate (ORR)

  Up to 2 year

Study Arms (5)

Group A

EXPERIMENTAL

Drug: BMS-986507; Drug: Osimertinib

Group B

EXPERIMENTAL

Drug: BMS-986507; Drug: Pembrolizumab

Group C

EXPERIMENTAL

Drug: BMS-986507; Drug: Nivolumab

Group D

EXPERIMENTAL

Drug: BMS-986507; Drug: Pumitamig

Group E

EXPERIMENTAL

Drug: BMS-986507; Drug: Pumitamig

Interventions

BMS-986507 DRUG

Specified dose on specified days

Also known as: Iza-bren, Izalontamab brengitecan

Group A; Group B; Group C; Group D; Group E

Osimertinib DRUG

Specified dose on specified days

Group A

Pembrolizumab DRUG

Specified dose on specified days

Group B

Pumitamig DRUG

Specified dose on specified days

Also known as: BMS-986545, BNT327, PM8002

Group D; Group E

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (64)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Local Institution - 0125

Maywood, Illinois, 60153, United States

NOT YET RECRUITING

Local Institution - 0065

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Local Institution - 0102

Columbus, Ohio, 43212, United States

NOT YET RECRUITING

Local Institution - 0134

Portland, Oregon, 97225, United States

NOT YET RECRUITING

Local Institution - 0052

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Local Institution - 0090

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Local Institution - 0014

Pittsburgh, Pennsylvania, 15232, United States

WITHDRAWN

Local Institution - 0103

Knoxville, Tennessee, 37920, United States

NOT YET RECRUITING

NEXT Oncology - Irving

Irving, Texas, 75039, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Local Institution - 0108

East Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

Local Institution - 0101

Subiaco, Western Australia, 6008, Australia

NOT YET RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

Local Institution - 0064

Newmarket, Ontario, L3Y 2P9, Canada

NOT YET RECRUITING

Local Institution - 0023

Ottawa, Ontario, K1H 8L6, Canada

WITHDRAWN

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Local Institution - 0105

Valdivia, Los Ríos Region, 5112129, Chile

NOT YET RECRUITING

Local Institution - 0048

Santiago, Santiago Metropolitan, 7500921, Chile

NOT YET RECRUITING

Local Institution - 0049

Santiago, Santiago Metropolitan, 8330032, Chile

NOT YET RECRUITING

Local Institution - 0047

Santiago, Santiago Metropolitan, 8420383, Chile

NOT YET RECRUITING

Local Institution - 0107

Viña del Mar, Valparaiso, 2520598, Chile

NOT YET RECRUITING

Local Institution - 0077

Nice, Alpes-Maritimes, 06189, France

WITHDRAWN

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

Bordeaux, Aquitaine, 33076, France

RECRUITING

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, 69008, France

RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône, 13385, France

RECRUITING

Local Institution - 0076

Caen, Calvados, 14076, France

NOT YET RECRUITING

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault, 34090, France

RECRUITING

Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

Hôpital Tenon

Paris, 75970, France

RECRUITING

Cro-Irccs

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

RECRUITING

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

Candiolo, Torino, 10060, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

RECRUITING

Local Institution - 0110

Ancona, 60126, Italy

NOT YET RECRUITING

Local Institution - 0093

Milan, 20141, Italy

NOT YET RECRUITING

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

Roma, 00168, Italy

RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

Amsterdam, 1066 CX, Netherlands

RECRUITING

CHUS - Hospital Clinico Universitario

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

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Barcelona [Barcelona], 08907, Spain

RECRUITING

Local Institution - 0059

Barcelona, Catalunya [Cataluña], 08036, Spain

WITHDRAWN

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, 28222, Spain

RECRUITING

Local Institution - 0118

Valencia, Valenciana, Comunitat, 46010, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Local Institution - 0127

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

H.R.U Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Local Institution - 0112

Seville, 41009, Spain

NOT YET RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Royal Free Hospital

London, England, NW32QG, United Kingdom

RECRUITING

Local Institution - 0021

Glasgow, Glasgow City, G12 0YN, United Kingdom

NOT YET RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2GW, United Kingdom

RECRUITING

Local Institution - 0001

Newcastle upon Tyne, NE7 7DN, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms

Interventions

osimertinib; pembrolizumab; Nivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): February 26, 2031
• Study Completion (Estimated): February 26, 2031
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CL (5); FR (9); IT (7); CA (6); NL (2); ES (13); AU (4); GB (4); US (14)