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 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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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Study Stats
Protocol No.
20-002315
Category
Hematology-Oncology
Oncology
Contact
Monica Rocha
Location
  • UCLA Parkside
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04505826
For detailed technical eligibility, visit ClinicalTrials.gov.