Phase 1Recruiting
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
- Sponsor
- Olema Pharmaceuticals, Inc. (Industry)
- Enrolment
- 180 planned
- 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
- Interventions
- OP-3136; Fulvestrant; Palazestrant
- Ages
- adults, older adults
- Registry
- NCT06784193
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Number of participants with dose-limiting toxicities in the Dose Escalation Arms
- Incidence of adverse events and laboratory abnormalities
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started