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

StatusActive, Not Recruiting
PhasePhase 1
Started
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.

Record History

  1. Primary completion date: Jan 2025 to Mar 2026 Completion date: Jul 2025 to Mar 2026 · Study sites revised (8)v3 Show 2 more changesShow less
    • Completion date: Jul 2025 to Mar 2026
    • Study sites revised (8)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jan 2023 to Jan 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 30 to confirmed 60 · Study sites: 5 to 8 · 2 morev2 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 60
    • Study sites: 5 to 8
    • Completion date: Dec 2023 to Jul 2025
    • Interventions: OP-1250 (Drug), Palbociclib (Drug) to Palazestrant (Drug), Palbociclib (Drug)
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05266105
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Pfizer
Conditions Breast Cancer
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov