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A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
Olema Pharmaceuticals, Inc.
This is a dose escalation and expansion study. The dose escalation part of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in participants with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. The dose expansion part of the study will further explore the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-cancer effectiveness.