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

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.

Trial Details

NCT ID
NCT05508906
Phase
PHASE1
Sponsor
Olema Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Palazestrant
  • Ribociclib
  • Alpelisib
  • Everolimus
  • Atirmociclib
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • San Francisco, California, United States|37.77493,-122.41942
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Orlando, Florida, United States|28.53834,-81.37924
  • Iowa City, Iowa, United States|41.66113,-91.53017

Key Eligibility Criteria

  • Female or male aged \>18 years.
  • Willing and able to participate and comply with all study requirements.
  • Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).
  • ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Positive Breast Cancer Trials on Trialify →