Clinical Trial

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Recruiting Phase 1
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-01-14; most recent amendment 2025-10-08.
Trial Details
NCT Number NCT06784193
Lead Sponsor Olema Pharmaceuticals, Inc.
Conditions Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Breast Cancer, Fulvestrant, Palazestrant
Enrollment 180 participants
Start Date 2024-12-16
Primary Completion 2027-05-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-10