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NCT05304962 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Regor Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
64
Enrollment target
8
Study locations

NCT05304962: Recruiting Phase 1 study of Breast Cancer, sponsored by Regor Pharmaceuticals.

NCT05304962 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Regor Pharmaceuticals. The registered enrollment target is 64 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05304962, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Regor Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
64 participants
Enrollment target
8
Study locations

Study 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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG RGT-419B
  • DRUG RGT-419B in combination with hormonal therapy

Study Locations (8)

California

  • University of California, San Diego - La Jolla
  • University California, Los Angeles - Los Angeles

Florida

  • Hem-Onc Associates of the Treasure Coast - Port Saint Lucie
  • Moffitt Cancer Center - Tampa

Georgia

  • Emory University - Atlanta

Massachusetts

  • Massachusetts General Hospital - Boston

Missouri

  • Washington University School of Medicine - St Louis

New York

  • New York Cancer and Blood Specialists - Port Jefferson Station

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2022-03-04
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

Regor Pharmaceuticals

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05304962

The ClinicalTrials.gov registry entry for NCT05304962 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Regor Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which RGT-419B is the first listed.

NCT05304962 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT05304962 about?

NCT05304962 is a clinical study titled "FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer". 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 ...

What is the current status of trial NCT05304962?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2022-03-04. Estimated completion is 2026-09-30.

What conditions does trial NCT05304962 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05304962?

The interventions under investigation include: RGT-419B (DRUG), RGT-419B in combination with hormonal therapy (DRUG).

Who is sponsoring clinical trial NCT05304962?

This trial is sponsored by Regor Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05304962 being conducted?

This trial has 8 study locations across California, Florida, Georgia, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.