Delving into the Latest Updates on TQB-3454 with Synapse

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.

Start Date07 Nov 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT06139367

/ 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.

Start Date01 Nov 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with TQB-3454

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100 Translational Medicine associated with TQB-3454

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100 Patents (Medical) associated with TQB-3454

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100 Deals associated with TQB-3454

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced biliary tract cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	05 Sep 2023
Hematologic Neoplasms	Phase 3	-	Shouyao Holdings (Beijing) Co. Ltd.	-
Acute Promyelocytic Leukemia	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	10 Jul 2023
Myelodysplastic Syndromes	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	10 Jul 2023
Relapsing acute myeloid leukemia	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	10 Jul 2023
Bile Duct Neoplasms	Phase 1	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Nov 2023
Advanced Malignant Solid Neoplasm	Phase 1	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	17 Aug 2020
IDH1 Mutation Cholangiocarcinoma	IND Approval	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	22 Jun 2020

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04481607 (ESMO_GI2024) Manual	Phase 1	IDH1 Mutation Cholangiocarcinoma Second line \| Third line IDH1 Mutation	36	TQB3454	enaabpwjic(mjznnvapga) = None azdxkekosu (fvgquqrgfa )	Positive	27 Jun 2024