RecruitingPhase 1NCT05508906

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Sponsor

Olema Pharmaceuticals, Inc.

Enrollment

190 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer

Summary

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1b study tests a drug called palazestrant (OP-1250) combined with various other targeted therapies in patients with hormone receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer. Palazestrant works by blocking estrogen receptors, which fuel this type of cancer's growth. **You may be eligible if...** - You are 18 years or older (male or female) - You have been diagnosed with advanced or metastatic ER-positive, HER2-negative breast cancer - Your cancer is confirmed by tissue testing - You have received prior hormone therapy (endocrine therapy) for breast cancer - You are in generally good health and can perform daily activities **You may NOT be eligible if...** - Your cancer is ER-negative or HER2-positive - You have uncontrolled brain metastases - You have significant heart rhythm problems - You have severe liver or kidney disease - You are pregnant or breastfeeding - You have received specific prior treatments that conflict with the study combinations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalazestrant

Complete estrogen receptor antagonist (CERAN)

DRUGRibociclib

All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.

DRUGAlpelisib

All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.

DRUGEverolimus

All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.

DRUGAtirmociclib

All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.

Locations(16)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

University of California San Francisco Health

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Advent Health Hematology and Oncology

Orlando, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

Regents of the University of Minnesota

Minneapolis, Minnesota, United States

Washington University, School of Medicine

St Louis, Missouri, United States

Ichan School of Medicine at Mount Sinai

New York, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Henry-Joyce Cancer Clinic, The Vanderbilt Clinic

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Macquarie Health

Sydney, New South Wales, Australia

Breast Cancer Research Center- Western Australia

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05508906

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