RecruitingRecruiting
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
NCT06618287 · Bristol-Myers Squibb
In plain English
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Official title
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
About this study
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 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 design
Enrollment target: 416 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-04
Estimated completion: 2031-02-26
Last updated: 2026-07-01
Interventions
Drug: BMS-986507Drug: OsimertinibDrug: PembrolizumabDrug: NivolumabDrug: Pumitamig
Primary outcomes
- • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (64)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
Miami, Florida, United States
Local Institution - 0125Not Yet Recruiting
Maywood, Illinois, United States
Local Institution - 0065Not Yet Recruiting
Iowa City, Iowa, United States
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Local Institution - 0102Not Yet Recruiting
Columbus, Ohio, United States
Local Institution - 0134Not Yet Recruiting
Portland, Oregon, United States
Local Institution - 0052Not Yet Recruiting
Portland, Oregon, United States
Local Institution - 0090Not Yet Recruiting
Portland, Oregon, United States
Local Institution - 0014Withdrawn
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
NEXT Oncology - IrvingRecruiting
Irving, Texas, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Liverpool HospitalRecruiting
Liverpool, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Local Institution - 0108Not Yet Recruiting
East Melbourne, Victoria, Australia
Local Institution - 0101Not Yet Recruiting
Subiaco, Western Australia, Australia
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
Local Institution - 0064Not Yet Recruiting
Newmarket, Ontario, Canada
Local Institution - 0023Withdrawn
Ottawa, Ontario, Canada
The Ottawa Hospital - General CampusRecruiting
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de MontréalRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Local Institution - 0105Not Yet Recruiting
Valdivia, Los Ríos Region, Chile
Local Institution - 0048Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0049Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0047Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0107Not Yet Recruiting
Viña del Mar, Valparaiso, Chile
Local Institution - 0077Withdrawn
Nice, Alpes-Maritimes, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting
Bordeaux, Aquitaine, France
Centre Leon BerardRecruiting
Lyon, Auvergne-Rhône-Alpes, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneRecruiting
Marseille, Bouches-du-Rhône, France
Local Institution - 0076Not Yet Recruiting
Caen, Calvados, France
Hôpital Arnaud de Villeneuve - CHU MontpellierRecruiting
Montpellier, Hérault, France
Gustave RoussyRecruiting
Villejuif, Val-de-Marne, France
Institut CurieRecruiting
Paris, France
Hôpital TenonRecruiting
Paris, France
Cro-IrccsRecruiting
Aviano, Friuli Venezia Giulia, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Lombardy, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting
Candiolo, Torino, Italy
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Tuscany, Italy
Local Institution - 0110Not Yet Recruiting
Ancona, Italy
Local Institution - 0093Not Yet Recruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
Leids Universitair Medisch CentrumRecruiting
Leiden, South Holland, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)Recruiting
Amsterdam, Netherlands
CHUS - Hospital Clinico UniversitarioRecruiting
Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Institut Català d'Oncologia - L'HospitaletRecruiting
Hospitalet, Barcelona [Barcelona], Spain
Local Institution - 0059Withdrawn
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0118Not Yet Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Fundación Jiménez DíazRecruiting
Madrid, Spain
Local Institution - 0127Not Yet Recruiting
Madrid, Spain
Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
H.R.U Málaga - Hospital GeneralRecruiting
Málaga, Spain
Local Institution - 0112Not Yet Recruiting
Seville, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Royal Free HospitalRecruiting
London, England, United Kingdom
Local Institution - 0021Not Yet Recruiting
Glasgow, Glasgow City, United Kingdom
University Hospitals Birmingham NHS Foundation TrustRecruiting
Birmingham, West Midlands, United Kingdom
Local Institution - 0001Not Yet Recruiting
Newcastle upon Tyne, United Kingdom