Recruiting

Phase 1

Phase 2

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

Sponsor:

Bristol-Myers Squibb

Code:

NCT06618287

Conditions

Lung Cancer

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986507

Osimertinib

Pembrolizumab

Nivolumab

Pumitamig

Study Details

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

Study ID

NCT06618287

Start date

Feb 4, 2025

Status verified date

Aug, 2026

Completion date

Feb 26, 2031

Anticipated

Primary completion date

Feb 26, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

416 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

experimental: Group B

experimental: Group C

experimental: Group D

experimental: Group E

Interventions

BMS-986507