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

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05304962
Trial Phases:	Phase I	Protocol IDs:	RGT-419B_01-101 (primary) NCI-2022-03843
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Regor Pharmaceuticals Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05304962

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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