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Clinical Trials associated with TQB-3454 [Translation] Phase Ib clinical trial of TQB3454 tablets in patients with hematological malignancies
主要目的:
评估TQB3454片单药或与阿扎胞苷联用在急性髓系白血病(AML)和骨髓增生异常综合征(MDS)患者中的安全性,确定II期推荐剂量(RP2D);
次要目的:
评估TQB3454片单药或与阿扎胞苷联用时TQB3454的药代动力学(PK)特征。
评估TQB3454片单药或与阿扎胞苷联用治疗AML或较高危MDS的初步有效性。
评估生物标志物与有效性之间的相关性。
[Translation] Primary objectives:
To evaluate the safety of TQB3454 tablets alone or in combination with azacitidine in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and to determine the recommended dose (RP2D) for Phase II;
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of TQB3454 tablets when used alone or in combination with azacitidine.
To evaluate the preliminary efficacy of TQB3454 tablets alone or in combination with azacitidine in the treatment of AML or higher-risk MDS.
To evaluate the correlation between biomarkers and efficacy.
/ Not yet recruitingPhase 1 A Randomized, Open, Parallel, Single Center Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3454 Tablets in Healthy Adult Subjects.
This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.
/ Not yet recruitingPhase 3 A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.
100 Clinical Results associated with TQB-3454
100 Translational Medicine associated with TQB-3454
100 Patents (Medical) associated with TQB-3454
100 Deals associated with TQB-3454