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A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

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Trial Profile

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Sep 2025

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At a glance

  • Drugs Palazestrant (Primary) ; Palbociclib (Primary)
  • Indications Advanced breast cancer; Brain metastases; HER2 negative breast cancer; Male breast cancer
  • Focus Adverse reactions; First in man; Pharmacodynamics; Proof of concept; Therapeutic Use
  • Sponsors Olema Pharmaceuticals

Most Recent Events

  • 24 Aug 2025 Status changed from active, no longer recruiting to completed.
  • 24 Oct 2023 Results ( as of March 17, 2023, n=86) assessing safety and efficacy of OP-1250 in patients with advanced or metastatic ER-positive, HER2-negative breast cancer presented at the 48th European Society for Medical Oncology Congress
  • 22 Oct 2023 According to an Olema Pharmaceuticals media release, positive phase 2 monotherapy results were presented at the European Society for Medical Oncology (ESMO) Congress 2023.

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