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    DRUG:

    zamzetoclax (GS-9716)

    i
    Other names: GS-9716, GS9716, GS 9716
    Associations

    News

    Trials
    Company:
    Gilead
    Drug class:
    MCL1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    6ms
    Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies (clinicaltrials.gov)
    P1, N=145, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    docetaxel • Trodelvy (sacituzumab govitecan-hziy) • zamzetoclax (GS-9716)
    7ms
    Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies (clinicaltrials.gov)
    P1, N=145, Recruiting, Gilead Sciences | Trial completion date: Jan 2027 --> Mar 2029 | Trial primary completion date: Jan 2027 --> Mar 2029
    Trial completion date • Trial primary completion date
    |
    docetaxel • Trodelvy (sacituzumab govitecan-hziy) • zamzetoclax (GS-9716)
    11ms
    Potential biomarkers for MCL1 inhibitor sensitivity. (PubMed, Cell Signal (Middlet))
    Currently, the MCL1 inhibitor GS-9716 is in clinical trials for TNBC therapy. If validated in clinical samples, this GS could potentially serve as a predictive biomarker for therapy response and help guide the selection of combination therapies to enhance the effectiveness of MCL1 inhibitors.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    zamzetoclax (GS-9716)
    almost2years
    Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies (clinicaltrials.gov)
    P1, N=195, Recruiting, Gilead Sciences
    Trial completion date • Trial primary completion date • Combination therapy
    |
    docetaxel • Trodelvy (sacituzumab govitecan-hziy) • zamzetoclax (GS-9716)
    over3years
    GS-9716: A potent, selective and orally bioavailable small molecule inhibitor of MCL1 for the treatment of cancer (AACR 2022)
    In addition to single agent activity, GS-9716 showed strong synergy with multiple anti-cancer therapies; robust in vitro synergy was observed with venetoclax in the AML models and as well as with paclitaxel in the TNBC models. Similar responses were also observed when GS-9716 was dosed with paclitaxel in the TNBC PDX models. GS-9716 is currently in Phase 1 clinical trial evaluating safety, tolerability and pharmacokinetics as monotherapy and in combination with anticancer therapies in adults with advanced solid tumors (NCT05006794).
    IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1)
    |
    Venclexta (venetoclax) • paclitaxel • zamzetoclax (GS-9716)