Olema Pharmaceuticals, Inc. recently announced the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment o...
This study supports the clinical evaluation of OP-1250 in combination with CDK4/6 inhibitors (palbociclib or ribociclib) and provides additional context to mechanisms of combination efficacy. OP-1250 is currently being evaluated in a Phase Ib clinical trial in combination with palbociclib and a ...
(NCT06016738) is a multicenter, randomized, open-label, phase 3 clinical trial comparing the efficacy and safety of palazestrant as a single agent to SOC ET (fulvestrant, anastrozole, letrozole, or exemestane) in patietns with ER+, HER2– MBC that relapsed or progressed on 1-2 prior ...
Trial design: Goals of this phase 1/2 are to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), to characterize the safety and PK profile, and to determine the preliminary activity of OP-1250 in subjects with HR+, HER2- ...
tumor tissue sampleTo evaluate whether ESR1 in circulating tumor DNA (ctDNA) can be correlated with response and/or activity of OP-1250To examine ctDNA pre- and post-therapy for mutESR1 and PIK3CA variants, and other relevant markersFor more information, please contact clinical{at}olemapharma....
However, most patients will progress and newer combinations such as with OP-1250 may provide improved clinical outcome. OP-1250 potently inactivates both wild-type ER and mutant forms of ER. The latter confers ligand independent activity and is a mechanism of resistance to standard of care ...