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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer; Lung Cancer

Treatments: Drug: Pembrolizumab; Drug: Osimertinib; Drug: BMS-986507; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06618287

CA244-0001

2024-514947-27 (EudraCT Number)

U1111-1308-2752 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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 B).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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238 participants in 3 patient groups

Group A

Experimental group

Treatment:

Drug: BMS-986507

Drug: Osimertinib

Group B

Experimental group

Treatment:

Drug: BMS-986507

Drug: Pembrolizumab

Group C

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986507