A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
OP-1250-001 (primary)
NCI-2020-13877
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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must not have received prior oral endocrine therapy > 2 weeks prior to first dose
- Must not have received prior fulvestrant, chemotherapy, antibody therapy, or investigational therapy = 4 weeks prior to the first dose
- Adequate hepatic function
- Adequate renal function
- Normal coagulation panel
- Willingness to use effective contraception
**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...
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