drugset / Trial / NCT06784193
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
RandomizedSequentialOpen-labelTreatment
Summary
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors. This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).
Timeline
- Start
- 2024-12-16
- Primary completion
- 2027-05-30
- Completion
- 2027-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | OP-3136 | Unknown | — | Oral |
| Subject | Palazestrant | Small molecule | — | — |