Recruiting Phase 1 / Phase 2

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

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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.

Condition: Lung Cancer, Breast Cancer
Tested: BMS-986507, Osimertinib, Pembrolizumab, Nivolumab, Pumitamig
Sponsor: Bristol-Myers Squibb

Who can join

Age: 18 years and older
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 11

Minimum age: 18 years
Study condition: Lung Cancer, Breast Cancer
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 5

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.

Where

65 sites, 57 recruiting

Liverpool Hospital

Liverpool, New South Wales, Australia

Recruiting

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Recruiting

St. John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Recruiting

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Recruiting

Cross Cancer Institute

Edmonton, Alberta, Canada

Recruiting

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Recruiting

and 59 more sites on ClinicalTrials.gov

Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.

Potential match only. Final eligibility is determined by the study team.