Actively Recruiting
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Led by Olema Pharmaceuticals, Inc. · Updated on 2025-10-10
180
Participants Needed
8
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with advanced or metastatic ER+ HER2- breast cancer, metastatic castration-resistant prostate cancer, or non-small cell lung cancer for Part 1
- Tumor is unresectable or metastatic with no effective or tolerable available therapies for Part 1A monotherapy
- Advanced or metastatic ER+ HER2- breast cancer progressed after at least 1 prior endocrine therapy and CDK 4/6 inhibitor for Parts 1B, 1C, and 2B
- No more than 2 prior lines of endocrine therapy (one combined with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or antibody-drug conjugate for Parts 1B, 1C, and 2B
- Up to 3 prior lines of endocrine therapy (one combined with CDK4/6 inhibitor) and up to 1 prior chemotherapy or antibody-drug conjugate for Part 2A monotherapy
- Up to 4 lines of prior systemic therapy including androgen receptor pathway inhibitor(s) for Part 2A in metastatic castration-resistant prostate cancer
You will not qualify if you...
- Prior treatment with any KAT6A/B inhibitor
- Advanced/metastatic symptomatic visceral disease with risk of short-term life-threatening complications
- Active or symptomatic central nervous system metastases or related complications needing treatment or steroids
- Lack of clinical and radiologic stability of CNS metastases in the 2 months before first dose
- History of cerebral vascular disease including transient ischemic attack within 6 months before first dose
- History or ongoing significant cardiac disease or impaired cardiac function within 6 months before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
START - Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
START - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
7
START - Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
8
Cancer Research South Australia
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
T
There may be multiple sites in this clinical trial Olema Clinical Trial Lead
CONTACT
O
Olema Medical Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here