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DRUG CLASS:

CDK2/4/6 inhibitor

2ms
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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fulvestrant • Setanxin (culmerciclib)
2ms
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
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fulvestrant • Setanxin (culmerciclib)
2ms
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
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Setanxin (culmerciclib)