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    DRUG:

    Saitanxin (culmerciclib)

    i
    Other names: TQB3616, TQB-3616, TQB 3616
    Company:
    Sino Biopharm
    Drug class:
    CDK2/4/6 inhibitor
    Related drugs:
    27d
    A single-arm, phase II, exploratory study of neoadjuvant treatment with Kudosil combined with Culmerciclib and dual-targeted therapy of trastuzumab and pertuzumab in HR+, HER2+ breast cancer (ChiCTR2600121242)
    P2, N=28, Recruiting, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital); The First Affiliated Hospital of Nanjing Medical U
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 positive • ER positive
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    Herceptin (trastuzumab) • Perjeta (pertuzumab) • letrozole • Saitanxin (culmerciclib)
    1m
    TQB3616-III-03: 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, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • Saitanxin (culmerciclib)
    1m
    TQB3616-ALTN-II-01: A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=21, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=126 --> 21 | Recruiting --> Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial termination
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    Focus V (anlotinib) • irinotecan • Saitanxin (culmerciclib)
    1m
    TQB3616-I-0001: A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics (clinicaltrials.gov)
    P1, N=40, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown status --> Completed | N=30 --> 40
    Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Saitanxin (culmerciclib)
    1m
    TQB3616-II-04: Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    fulvestrant • Saitanxin (culmerciclib)
    1m
    TQB3616-III-01: TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (clinicaltrials.gov)
    P3, N=293, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    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 • Saitanxin (culmerciclib)
    1m
    TQB3616-II-01: A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=122, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Saitanxin (culmerciclib)
    5ms
    Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial. (PubMed, Signal Transduct Target Ther)
    In conclusion, this randomized clinical trial met its primary outcome. Culmerciclib plus fulvestrant is well tolerated and leads to a significant gain in PFS of pretreated HR-positive HER2-negative ABC patients.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Saitanxin (culmerciclib)
    5ms
    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 • Saitanxin (culmerciclib)
    6ms
    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
    |
    Saitanxin (culmerciclib)
    11ms
    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 • Saitanxin (culmerciclib)
    12ms
    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 • Saitanxin (culmerciclib)