drugset / Trial / NCT06234397
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Phase 1
Recruiting
245 enrolled
Hanmi Pharmaceutical Company Limited
Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.
Timeline
- Start
- 2023-12-28
- Primary completion
- 2027-08
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BH3120 | Unknown | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.