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    DRUG:

    AVZO-021

    i
    Other names: AVZO-021, ARTS-021
    Associations

    News

    Trials
    Company:
    Allorion Therap, Avenzo Therap
    Drug class:
    CDK2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    8ms
    Study of ARTS-021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=192, Recruiting, Allorion Therapeutics Inc | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1)
    |
    HER-2 negative • CCNE1 amplification
    |
    Ibrance (palbociclib) • carboplatin • fulvestrant • letrozole • AVZO-021
    10ms
    ARTS-021-1001: Phase I/II study of ARTS-021, a potent, oral administrated, selective CDK2 inhibitor, in advanced or metastatic solid tumors (ESMO 2023)
    Trial design This is a first in human, open label, multicenter phase1/2 dose escalation and dose expansion study to evaluate the safety, tolerability, PK, PD, and anti-tumor activity of ARTS-021 1) as a single agent in advanced or metastatic CCNE-1 amplifed solid tumors; 2) in combination with Carboplatin to treat refractory/resistant CCNE-1 amplified ovarian cancer that has failed standard therapies; 3) in combination with endocrine therapy (fulvestrant/letrozole) and CDK4/6 inhibitor(palbociclib/ribociclib/abemaciclib) to treat HR+ HER2- breast cancer patients have failed standard therapies. The secondary endpoint of phase 2 study will be safety/tolerability. Archival tumor and paired fresh tumor biopsy will be collected throughout the study for exploratory pharmacodynamics (PD) and biomarker evaluation.
    P1/2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1) • CDK1 (Cyclin-dependent kinase 1)
    |
    HER-2 negative • CCNE1 amplification
    |
    Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • AVZO-021
    12ms
    Study of ARTS-021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=192, Not yet recruiting, Allorion Therapeutics Inc
    New P1/2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1)
    |
    HER-2 negative • CCNE1 amplification
    |
    Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • AVZO-021