A Phase I/IIa, 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
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Study 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. Main objective Find out if BMS-986507 is safe and to determine the maximum dose that is safe for being given to the patients in combination with other treatments and select some safe doses to be evaluated in a large group of patients. BMS-986507 will be evaluated in two groups of lung cancer patients: patients with a type of lung cancer called EGFRmt non-small cell lung cancer (NSCLC) and patients with a type of lung cancer called EGFRwt NSCLC.
To assess iza-bren combinations in advanced solid tumors, with initial enrollment of patients with mutated EGFR NSCLC (group A) or wild-type EGFR NSCLC (group B).
The study will include a dose expansion phase only for group A, and dose escalation (part 1) and dose expansion (part 2) phases for group B.
- 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 allowedGroup 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.Key inclusion criteria are age ≥18 years, ECOG performance status 0–1, pathologically confirmed locally advanced or metastatic NSCLC, and measurable disease by RECIST v1.1. Additional eligibility criteria for group A include a known EGFR mutation, no prior systemic therapy for locally advanced or metastatic NSCLC (including tyrosine kinase inhibitors), and suitability for first-line osimertinib. Additional eligibility criteria for group B include no EGFR mutations and, for part 2 only, no prior systemic therapy for locally advanced or metastatic NSCLC and available tumor cell PD-L1 expression data.
- 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.
- Key exclusion criteria for both groups are mixed NSCLC/SCLC histology, and a history of interstitial lung disease, pneumonitis, and/or serious recurrent infections.
Clinical Study Information for Healthcare Providers
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