Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Kelly Mccann

Description

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.

Official Title

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

Details

This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label, first--in--human study to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A [Dose Escalation] and Part B [Dose Expansion]) and Phase II. Additionally, all subjects (Phase I and Phase II) will be eligible to participate in 1 of 2 sub-studies. Patients 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. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0.

Keywords

Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, Breast Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Gastrointestinal disease
  • Significant renal disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities
  • Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
  • Pregnancy or breastfeeding

Locations

  • UCLA Hematology/Oncology
    Los Angeles California 90404 United States
  • OHSU Knight Cancer Institute
    Portland Oregon 97239 United States
  • Providence Portland Medical Center
    Portland Oregon 97213 United States

Lead Scientist at UCLA

  • Kelly Mccann
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 19 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Olema Pharmaceuticals, Inc.
ID
NCT04505826
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 153 people participating
Last Updated