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    DRUG:

    culmerciclib (TQB3616)

    i
    Other names: TQB3616, TQB-3616, TQB 3616
    Company:
    Sino Biopharm
    Drug class:
    CDK2/4/6 inhibitor
    Related drugs:
    14d
    TQB3616-II-03: TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P2, N=26, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=118 --> 26 | Trial completion date: Dec 2024 --> Sep 2025 | Not yet recruiting --> Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial completion date • Trial termination
    |
    culmerciclib (TQB3616)
    5ms
    TQB3616-Ⅲ-02: 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. | Trial primary completion date: Jun 2024 --> Jul 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • culmerciclib (TQB3616)
    7ms
    Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=75, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • culmerciclib (TQB3616)
    8ms
    CDK4/6 Inhibitor Can Improve Niraparib Sensitivity and Reverse Acquired Drug Resistance Through Endonuclease G Nuclear Translocation in BRCA Wild-Type Ovarian Cancer: A Vitro Study. (PubMed, BJOG)
    Combined therapy with the CDK4/6 inhibitor TQB-3616 and niraparib ZL-2306 showed synergistic antitumour effects against BRCA wild-type ovarian cancer without increasing the toxicity of each drug. The antitumour effect may be related to mitochondrial apoptosis, where EndoG nuclear translocation plays a critical role. This study proposes combined therapy of CDK4/6 and PARP inhibitors as a novel approach for the treatment of refractory ovarian cancer.
    Journal
    |
    BRCA (Breast cancer early onset)
    |
    BRCA wild-type
    |
    Zejula (niraparib) • culmerciclib (TQB3616)
    9ms
    Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=75, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1/2 trial
    |
    fulvestrant • culmerciclib (TQB3616)
    12ms
    TRIM4 modulates the ubiquitin-mediated degradation of hnRNPDL and weakens sensitivity to CDK4/6 inhibitor in ovarian cancer. (PubMed, Front Med)
    Patient-derived ovarian cancer organoid models were established to evaluate the effectiveness of TQB3616...Overall, our findings suggest that TRIM4 modulates ubiquitin-mediated degradation of hnRNPDL and weakens sensitivity to CDK4/6 inhibitors in ovarian cancer treatment. TRIM4 may serve as a valuable biomarker for predicting sensitivity to CDK4/6 inhibitors in ovarian cancer.
    Journal
    |
    HNRNPD (Heterogeneous Nuclear Ribonucleoprotein D) • CDKN2C (Cyclin Dependent Kinase Inhibitor 2C) • TRIM4 (Tripartite Motif Containing 4)
    |
    culmerciclib (TQB3616)
    1year
    Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial • Metastases
    |
    fulvestrant • culmerciclib (TQB3616)
    1year
    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
    1year
    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)
    over1year
    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
    almost2years
    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)
    almost2years
    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)