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 (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.

Trial Details

NCT ID
NCT05304962
Phase
PHASE1
Sponsor
Regor Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • RGT-419B
  • RGT-419B in combination with hormonal therapy
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Port Saint Lucie, Florida, United States|27.29393,-80.35033
  • Tampa, Florida, United States|27.94752,-82.45843
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • 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 advanc…
  • Measurable AND evaluable lesions at baseline per RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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