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
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 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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
20-002315
Category
Breast Cancer
Contact
Monica Rocha
Location
  • UCLA Parkside
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04505826
For detailed technical eligibility, visit ClinicalTrials.gov.