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

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).

Trial Details

NCT ID
NCT06784193
Phase
PHASE1
Sponsor
Olema Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • OP-3136
  • Fulvestrant
  • Palazestrant
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Sarasota, Florida, United States|27.33643,-82.53065
  • New Orleans, Louisiana, United States|29.95465,-90.07507
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
  • Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging …
  • Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have p…
  • Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have …

For full eligibility, visit ClinicalTrials.gov.

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