Clinical Trial

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated November 24, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-02-23; most recent amendment 2025-11-19.
Status change: Recruiting → Active, Not Recruiting 2024-06-04
Trial Details
NCT Number NCT05266105
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Pfizer
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2021-12-10
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-11-24