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    DRUG:

    RGT-419B

    i
    Other names: RGT-419B, RGT 419B, RGT419B
    Company:
    Regor, Roche
    Drug class:
    CDK4 inhibitor, CDK6 inhibitor, CDK2 inhibitor
    Related drugs:
    10d
    FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=64, Recruiting, Regor Pharmaceuticals Inc. | N=18 --> 64
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B
    4ms
    FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=18, Recruiting, Regor Pharmaceuticals Inc. | Trial completion date: Aug 2024 --> Sep 2026 | Trial primary completion date: Feb 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    RGT-419B
    9ms
    A Phase I Study of RGT-419B in Chinese Patients (clinicaltrials.gov)
    P1, N=40, Recruiting, Regor Pharmaceuticals Inc.
    New P1 trial • Metastases
    |
    RGT-419B
    1year
    First-in-human phase 1A study of RGT-419B, a next generation CDK4 inhibitor, in patients (pts) with hormone receptor positive (HR+) HER2- advanced/metastatic breast cancer (ABC) who progressed on prior CDK4/6 inhibitors (CDK4/6i) (SABCS 2023)
    All had prior palbociclib + ET (2 pts had abemaciclib or ribociclib after palbociclib); a majority received fulvestrant (67%) and prior chemotherapy (50%). RGT-419B, with potent selective CDK4 activity, CDK2 activity and CDK6 selectivity, demonstrated a favorable safety and PK profile in an ongoing phase I study, with no grade 3 or higher TRAEs observed thus far. RGT-419B administered as once daily monotherapy also demonstrated preliminary evidence of efficacy as well. Dose expansions of RGT-419B as a single agent and in combination with ET in pts with HR+/HER2- ABC following prior CDK4/6i progression are planned.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK2 (Cyclin-dependent kinase 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • RGT-419B • Undisclosed CDK4/6 inhibitor
    1year
    First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=18, Recruiting, Regor Pharmaceuticals Inc. | Active, not recruiting --> Recruiting | N=12 --> 18
    Enrollment open • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B
    over1year
    First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Regor Pharmaceuticals Inc. | Recruiting --> Active, not recruiting | N=48 --> 12
    Enrollment closed • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B
    over2years
    First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Regor Pharmaceuticals Inc.
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B