Breast Cancer Clinical Trial
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
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.
Full Description
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 Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Gastrointestinal disease
Significant renal disease
Significant cardiovascular disease
Significant ECG abnormalities
Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
Pregnancy or breastfeeding
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There are 9 Locations for this study
Orlando Florida, 32804, United States
Sarasota Florida, 34232, United States
Portland Oregon, 97239, United States
Nashville Tennessee, 37203, United States
Sydney New South Wales, 2109, Australia
Westmead New South Wales, 2145, Australia
Auchenflower Queensland, 4066, Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3000, Australia
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