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Official Title
First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer
Phase
Phase 1
Sponsor
Regor Pharmaceuticals Inc.
Enrollment
64
Timeline
Mar 2022 → Sep 2026
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Male or female \>/= 18 years old
- 2ECOG Performance Status 0 to 1
- 3Subjects 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.
- 4Measurable AND evaluable lesions at baseline per RECIST v1.1.
- 5Eligible subjects must meet all of the following criteria:
- 6Progression 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);
- 7Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
- 8Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)
- 9Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
- 10≤ 1 prior line of chemotherapy in the metastatic setting
- 11Adequate organ function
- 12Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- 1Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
- 2Pregnant or planning to become pregnant
- 3Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- 4Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
- 5Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- 6History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
Locations
8 sites participating in this study
Emory University
Atlanta, Georgia 30322
Kevin Kalinsky, MD, MS
University of California, San Diego
La Jolla, California 92037
Rebecca Shatsky, MD
University California, Los Angeles
Los Angeles, California 90404
Saeed Sadeghi, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →