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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04505826
Protocol IDs
OP-1250-001 (primary)
NCI-2020-13877
Study Sponsor
Olema Pharmaceuticals, Inc.

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.

Eligibility

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. Must not have received prior oral endocrine therapy > 2 weeks prior to first dose
  3. Must not have received prior fulvestrant, chemotherapy, antibody therapy, or investigational therapy = 4 weeks prior to the first dose
  4. Adequate hepatic function
  5. Adequate renal function
  6. Normal coagulation panel
  7. Willingness to use effective contraception
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.