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    DRUG:

    AUR102

    i
    Other names: AUR102, XL102, AUR-102 , AUR 102
    Associations

    News

    Trials
    Company:
    Dr. Reddy’s, Exelixis
    Drug class:
    CDK7 inhibitor
    Related drugs:
    Associations

    News

    Trials
    6ms
    XL102-101: Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101) (clinicaltrials.gov)
    P1, N=52, Terminated, Exelixis | N=373 --> 52 | Trial completion date: Oct 2024 --> May 2024 | Active, not recruiting --> Terminated; Business reasons
    Enrollment change • Trial completion date • Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    abiraterone acetate • fulvestrant • prednisone • AUR102
    9ms
    XL102-101: Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101) (clinicaltrials.gov)
    P1, N=373, Active, not recruiting, Exelixis | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    abiraterone acetate • fulvestrant • prednisone • AUR102
    over1year
    Novel covalent CDK7 inhibitor potently induces apoptosis in acute myeloid leukemia and synergizes with Venetoclax. (PubMed, J Exp Clin Cancer Res)
    Taken together, XL102 with Venetoclax led to synergistic effects in overcoming resistance and provided a strong rationale for clinical evaluation of XL102 as a single agent and in combination with Venetoclax.
    Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CDK1 (Cyclin-dependent kinase 1)
    |
    Venclexta (venetoclax) • AUR102
    3years
    First in human phase 1 dose escalation and expansion study of the safety and pharmacokinetics of the oral CDK7 inhibitor XL102 as a single-agent and in combination therapy in patients with inoperable locally advanced or metastatic solid tumors, including breast cancer (SABCS 2021)
    In the dose-escalation stages (modified interval 3+3 design), a maximum tolerated (MTD) and/or recommended XL102 dose (RD) for use alone and in combination therapy with standard dose fulvestrant (HR+BC) or abiraterone/prednisone (mCRPC) will be established in independent strata. Accrual: The study began enrolling patients in February 2021 and is ongoing. Total enrollment estimated to be up to 298 subjects.
    Clinical • P1 data • PK/PD data • Combination therapy • IO biomarker
    |
    CDK7 (Cyclin Dependent Kinase 7)
    |
    HR positive • CDK7 overexpression
    |
    abiraterone acetate • fulvestrant • AUR102
    almost4years
    Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=298, Recruiting, Exelixis
    Clinical • New P1 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    abiraterone acetate • fulvestrant • prednisone • AUR102