[Translation] An open, multicenter, Phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic characteristics, and preliminary efficacy of TSN084 tablets in the treatment of subjects with advanced malignant tumors

主要研究目的：评估TSN084片在晚期或转移性恶性肿瘤受试者中的安全性、耐受性、剂量限制性毒性（DLTs）和初步抗肿瘤活性，确定最大耐受剂量（MTD）、扩展期推荐剂量（RDE）和II期临床研究推荐剂量。次要研究目的：评估TSN084片药代动力学（PK）特征和初步抗肿瘤活性。探索性研究目的：探索TSN084的暴露量/剂量与安全性以及临床疗效之间的关系以及生物标志物。

[Translation]

The main purpose of the study is to evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and preliminary anti-tumor activity of TSN084 tablets in subjects with advanced or metastatic malignancies, and to determine the maximum tolerated dose (MTD), recommended dose for extension (RDE) and recommended dose for Phase II clinical studies. The secondary purpose of the study is to evaluate the pharmacokinetic (PK) characteristics and preliminary anti-tumor activity of TSN084 tablets. The purpose of the exploratory study is to explore the relationship between the exposure/dose of TSN084 and safety and clinical efficacy, as well as biomarkers.

Start Date20 Jul 2022

Sponsor / Collaborator

Taili Biotechnology Shanghai Co Ltd.

NCT06386705 / RecruitingPhase 1

A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors.

TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China.

Start Date20 Jul 2022

Sponsor / Collaborator

Taili Biotechnology Shanghai Co Ltd.

NCT05300438 / Active, not recruitingPhase 1

TSN084 is a novel type II protein kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies.

Start Date18 Feb 2022

Sponsor / Collaborator

Taili Biotechnology Shanghai Co Ltd.

100 Clinical Results associated with CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8

100 Translational Medicine associated with CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8

0 Patents (Medical) associated with CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8

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