Open
Actively Recruiting
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
About
Brief Summary
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
- Must not have received prior oral endocrine therapy < 2 weeks prior to first dose
- Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, 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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Study Stats
Protocol No.
20-002315
Category
Breast Cancer
Principal Investigator
Contact
Location
- UCLA Parkside
- UCLA Santa Monica
- UCLA Westwood