FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
NCT05304962
This study is recruiting at 7 US sites in 6 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Regor Pharmaceuticals Inc.
- Last updated on ClinicalTrials.gov
- August 12, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- University of California, San Diego · La Jolla, CA
- University California, Los Angeles · Los Angeles, CA
Florida · 1
- Moffitt Cancer Center · Tampa, FL
Georgia · 1
- Emory University · Atlanta, GA
Massachusetts · 1
- Massachusetts General Hospital · Boston, MA
Missouri · 1
- Washington University School of Medicine · St Louis, MO
New York · 1
- New York Cancer and Blood Specialists · Port Jefferson Station, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.