● Recruiting

FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

Condition: Breast Cancer · Sponsor: Regor Pharmaceuticals Inc.

PhasePhase 1

Planned participants64

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.

This description comes directly from the study's public registry record.

Talk to the study team

Joanna Dojillo, MSc · 617-315-9070 · joanna.dojillo@regor.com

Regor Pharmaceuticals Central Office · 617-315-9070 · rgt-419b_01-101@regor.com

Always discuss trial participation with your own doctor first.

Locations (8)

University of California, San Diego	La Jolla, California, United States	Recruiting
University California, Los Angeles	Los Angeles, California, United States	Recruiting
Hem-Onc Associates of the Treasure Coast	Port Saint Lucie, Florida, United States	Active Not Recruiting
Moffitt Cancer Center	Tampa, Florida, United States	Recruiting
Emory University	Atlanta, Georgia, United States	Recruiting
Massachusetts General Hospital	Boston, Massachusetts, United States	Recruiting
Washington University School of Medicine	St Louis, Missouri, United States	Recruiting
New York Cancer and Blood Specialists	Port Jefferson Station, New York, United States	Recruiting

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Source record: clinicaltrials.gov/study/NCT05304962