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A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer


Active: Yes
Cancer Type: Breast Cancer
Unknown Primary
NCT ID: NCT04505826
Trial Phases: Phase I
Phase II
Protocol IDs: OP-1250-001 (primary)
NCI-2020-13877
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Olema Pharmaceuticals, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT04505826

Summary

This clinical trial is a Phase 1-2, open-label, multi-center, dose-escalation and expansion
study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of
daily oral administration of OP-1250.

Objectives

OP-1250 is a small molecule Complete Estrogen Receptor ANtagonist (CERAN). OP-1250 potently
competes with the endogenous activating estrogenic ligand 17-beta estradiol for binding in
the ligand binding pocket. OP-1250 blocks estrogen-driven transcriptional activity, inhibits
estrogen-driven breast cancer cell growth, and induces degradation of the estrogen receptor.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.