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    DRUG:

    Setanxin (culmerciclib)

    i
    Other names: TQB3616, TQB-3616, TQB 3616
    Company:
    Sino Biopharm
    Drug class:
    CDK2/4/6 inhibitor
    Related drugs:
    4d
    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=8, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=75 --> 8 | Trial completion date: Apr 2027 --> Nov 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2027 --> Nov 2025; 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 • Trial primary completion date
    |
    fulvestrant • Setanxin (culmerciclib)
    26d
    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
    |
    Setanxin (culmerciclib)
    6ms
    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 • Setanxin (culmerciclib)
    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 • Setanxin (culmerciclib)
    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) • Setanxin (culmerciclib)
    10ms
    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 • Setanxin (culmerciclib)
    1year
    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)
    |
    Setanxin (culmerciclib)
    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 • Setanxin (culmerciclib)
    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
    |
    Setanxin (culmerciclib) • 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 • Setanxin (culmerciclib)
    almost2years
    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 • Setanxin (culmerciclib) • 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 • Setanxin (culmerciclib)