FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
Recruiting now · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05304962
- Run by
- Regor Pharmaceuticals Inc.
- People needed
- 64
- Starts
- 2022-03-04
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female >/= 18 years old
- ECOG Performance Status 0 to 1
- Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.
- Measurable AND evaluable lesions at baseline per RECIST v1.1.
- Eligible subjects must meet all of the following criteria:
- Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);
- Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
- Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)
- Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
- ≤ 1 prior line of chemotherapy in the metastatic setting
- Adequate organ function
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
- Pregnant or planning to become pregnant
- Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
- Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
Where it is running
- New York Cancer and Blood Specialists — Port Jefferson Station, New York, United States (enrolling)
- University California, Los Angeles — Los Angeles, California, United States (enrolling)
- University of California, San Diego — La Jolla, California, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Hem-Onc Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
Full record on ClinicalTrials.gov
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