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

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• 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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Olema Pharmaceuticals, Inc.

Last updated on ClinicalTrials.gov

October 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites