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
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of participants with adverse events (AEs)
Time frame: Up to 3 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 years
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
Time frame: Up to 3 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 3 years
Secondary Endpoints
Maximum observed serum concentration (Cmax)
Time of maximum observed concentration (Tmax)
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Eligibility 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. * Group D: Participants must …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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