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
Qualifiers
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 must not have untreated CNS metastases. 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
Treatments tested in this trial
- BMS-986517
Treatment groups
315 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov