Clinical Trial

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Recruiting Phase 1
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Summary
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-08-18; most recent amendment 2025-10-20.
Status change: Active, Not Recruiting → Recruiting 2025-10-16
Status change: Recruiting → Active, Not Recruiting 2025-08-12
Status change: Not Yet Recruiting → Recruiting 2022-09-22
Trial Details
NCT Number NCT05508906
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Novartis, Pfizer
Conditions Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer, Locally Advanced Breast Cancer
Enrollment 190 participants
Start Date 2022-08-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-22