A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
ConditionSolid Tumours
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have an ECOG performance status of 0 to 1.
Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Disqualifiers
Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
Participants must not have history of serious recurrent infections.
Participants must not have impaired cardiac function or history of severe heart disease.
Trial design
Design model
Sequential
Treatments tested in this trial
BMS-986517
DrugSpecified dose on specified days
Pumitamig
DrugSpecified dose on specified days
Treatment groups
540 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Part 1A Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 1B Combination Dose EscalationExperimental treatment 2 interventions
Group C: Part 1C: Monotherapy PD Sub-studyExperimental treatment 1 intervention
Group D: Part 2A: Monotherapy Dose Expansion Cohort AExperimental treatment 1 intervention
Group E: Part 2A: Monotherapy Dose Expansion Cohort BExperimental treatment 1 intervention
Group F: Part 2A: Monotherapy Dose Expansion Cohort CExperimental treatment 1 intervention
Group G: Part 2B: Combination Dose Expansion Cohort AExperimental treatment 2 interventions
Group H: Part 2B: Combination Dose Expansion Cohort BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AE)
Time frame
Up to approximately 2 years2
Number of Participants with Serious Adverse Events (SAE)
Time frame
Up to approximately 2 years3
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
For part 1 only
Time frame
Up to Day 214
Number of Participants with AEs Leading to Discontinuation
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Time frame
Up to approximately 3 years2
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Time frame
Up to approximately 3 years3
Maximum Plasma Concentration (Cmax)
Time frame
Up to approximately 2 years4
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov