Actively Recruiting
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
Led by Regor Pharmaceuticals Inc. · Updated on 2026-04-02
64
Participants Needed
8
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older
- ECOG Performance Status of 0 to 1
- Diagnosis of estrogen receptor-positive, HER2-negative advanced breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV)
- Measurable and evaluable lesions at baseline according to RECIST v1.1
- Disease progression after 1 line of prior CDK4/6 inhibitor therapy combined with hormonal therapy in the metastatic setting or up to 1 additional line in the adjuvant setting
- Prior therapy for at least 3 months in the metastatic setting or 6 months in the adjuvant setting before progression
- Disease progression after 3 or fewer lines of prior hormonal therapy
- Prior hormonal therapy agents must be formally approved therapies including SERD, SERM, or aromatase inhibitors
- No more than 1 prior line of chemotherapy in the metastatic setting
- Adequate organ function
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Presence of visceral metastases causing severe organ dysfunction or rapid disease progression
- Pregnant or planning to become pregnant
- Prior radiation to more than 25% of bone marrow or inadequate bone marrow function or significant organ damage
- Recent major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to study start
- Active, serious medical conditions not well controlled with medications
- History of allergic reactions to compounds similar to the study drugs
AI-Screening
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Trial Site Locations
Total: 8 locations
1
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
University California, Los Angeles
Los Angeles, California, United States, 90404
Actively Recruiting
3
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Active, Not Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02142
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
Research Team
J
Joanna Dojillo, MSc
CONTACT
R
Regor Pharmaceuticals Central Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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