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COMPLETED
NCT04505826
PHASE1/PHASE2

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Sponsor: Olema Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2020-08-13

Completion Date

2024-07-30

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DRUG

OP-1250

Complete Estrogen Receptor ANtagonist (CERAN)

Locations (19)

UCLA Hematology/Oncology

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

University of Miami, Sylvester Comprehensive Cancer Center

Deerfield Beach, Florida, United States

Advent Health

Orlando, Florida, United States

Florida Cancer Center

Sarasota, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Macquarie University

Sydney, New South Wales, Australia

Westmead

Westmead, New South Wales, Australia

ICON Cancer Centre

Auchenflower, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia