Clinical trial · Interventional
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
NCT07160725CI-TRIAL-00121553recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986517 | Drug | — | UNRESOLVED |
| Pumitamig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Part 1A Monotherapy Dose Escalation
- interventionNames
- Drug: BMS-986517
- type
- EXPERIMENTAL
- label
- Part 1B Combination Dose Escalation
- interventionNames
- Drug: BMS-986517
- Drug: Pumitamig
- type
- EXPERIMENTAL
- label
- Part 1C: Monotherapy PD Sub-study
- interventionNames
- Drug: BMS-986517
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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. Exclusion Criteria * 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. * For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy. * For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis. * For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding. * Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.