Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1
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
In brief
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).
Key facts
- Study ID
- NCT06784193
- Run by
- Olema Pharmaceuticals, Inc.
- People needed
- 180
- Starts
- 2024-12-16
- Expected to finish
- 2027-08-30
- Last updated by the study team
- 2025-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
- University Medical Center - New Orleans — New Orleans, Louisiana, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- START - Midwest — Grand Rapids, Michigan, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- START - San Antonio — San Antonio, Texas, United States (enrolling)
- START - Mountain Region — West Valley City, Utah, United States (enrolling)
- Cancer Research South Australia — Adelaide, South Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.