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

ClinicalTrials.gov ID: NCT05304962

Public ClinicalTrials.gov record NCT05304962. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer

Study identification

NCT ID: NCT05304962
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Regor Pharmaceuticals Inc.; Industry
Enrollment: 64 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

RGT-419B Drug
RGT-419B in combination with hormonal therapy Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 3, 2022
Primary completion: Sep 29, 2026
Completion: Dec 29, 2026
Last update posted: Apr 1, 2026

2022 – 2026

United States locations

U.S. sites: 8
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
University of California, San Diego	La Jolla	California	92037	Recruiting
University California, Los Angeles	Los Angeles	California	90404	Recruiting
Hem-Onc Associates of the Treasure Coast	Port Saint Lucie	Florida	34952	Active, not recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Emory University	Atlanta	Georgia	30322	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02142	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
New York Cancer and Blood Specialists	Port Jefferson Station	New York	11776	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05304962, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 1, 2026 · Synced Apr 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05304962 live on ClinicalTrials.gov.

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