RecruitingPhase 1Phase 2NCT06618287
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
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
Sponsor
Bristol-Myers Squibb
Enrollment
416 participants
Start Date
Feb 4, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria4
- 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.
Interventions
DRUGBMS-986507
Specified dose on specified days
DRUGOsimertinib
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGPumitamig
Specified dose on specified days
Locations(63)
View Full Details on ClinicalTrials.gov
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NCT06618287
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