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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.
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.
Primary Outcome
Number of subjects who have a confirmed DLT at each cohort dose level in singlet and doublet study arms during the first 28-day cycle of RGT-419B treatment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT05304962 shows while recruiting
NCT05304962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT05304962's enrollment target sits among peer trials
64 725th of 1224 higher than 499 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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