FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
18 Years and older, Male and Female
RGT-419B_01-101 (primary)
NCI-2022-03843
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.
Eligibility
- 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
Treatment Sites in Georgia
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