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    DRUG:

    culmerciclib (TQB3616)

    i
    Other names: TQB3616, TQB-3616, TQB 3616
    Company:
    Sino Biopharm
    Drug class:
    CDK4 inhibitor, CDK6 inhibitor, CDK2 inhibitor
    Related drugs:
    26d
    Drug-Drug Interaction (DDI) Study for TQB3616 (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial
    |
    culmerciclib (TQB3616) • itraconazole • rifampicin
    2ms
    TQB3616-III-01: TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (clinicaltrials.gov)
    P3, N=287, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2025
    Enrollment closed • Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • culmerciclib (TQB3616)
    9ms
    A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=154, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=89 --> 154 | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Mar 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    gemcitabine • paclitaxel • capecitabine • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • culmerciclib (TQB3616) • TQB2930
    11ms
    To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=432, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    fulvestrant • culmerciclib (TQB3616)
    12ms
    The Potent Novel CDK4/6 Inhibitor TQB3616 in Hormone Receptor Positive Breast Cancer: Preclinical Characterization with in vitro and Human Tumor Xenograft Models. (PubMed, Breast Cancer (Dove Med Press))
    Oral administration of TQB3616 showed more potent antitumor activity than abemaciclib in an in vitro breast cancer xenograft model, causing significant tumor regression associated with sustained target inhibition in tumor tissue and manageable in vivo toxicity. The results of this study indicate that TQB3616 is a novel CDK4/6 inhibitor, and its highly effective antitumor activity against breast cancer is expected to yield promising therapeutic effects in clinical studies.
    Preclinical • Journal
    |
    ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HR positive • HER-2 negative • ER positive + HER-2 negative
    |
    Verzenio (abemaciclib) • culmerciclib (TQB3616)
    12ms
    Mass Balance Study of TQB3616 (clinicaltrials.gov)
    P1, N=8, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial
    |
    culmerciclib (TQB3616)
    over1year
    Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer (clinicaltrials.gov)
    P3, N=1946, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • culmerciclib (TQB3616)
    over1year
    Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer (clinicaltrials.gov)
    P3, N=1946, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • culmerciclib (TQB3616)
    over2years
    TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (clinicaltrials.gov)
    P3, N=287, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    fulvestrant • culmerciclib (TQB3616)
    over2years
    To Evaluate the Efficacy and Safety of TQB3616 in Combination With Flulvesant Versus Placebo in Combination With Flulvesant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=428, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • culmerciclib (TQB3616)
    almost3years
    Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Peking University
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    benmelstobart (APL-502) • culmerciclib (TQB3616)
    over3years
    A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • culmerciclib (TQB3616)
    over3years
    A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • culmerciclib (TQB3616)