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Clinical Trial Summary

The purpose of this single- arm, open-lable, dose escalation + dose expansion study is to evalulate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.


Clinical Trial Description

This is the first-in-human trial with TGRX-678 which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerence to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the maximal tolerated dose (MTD) and recommended phase II dose (RP2D), and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678 is evaluated based on the changes in peripheral blood cells and disease-associated cytogenetic markers. The safety, tolerability and efficacy profiles, along with pharmacokinetic analysis, will be assessed together to determine the optimal dose for expansion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05434312
Study type Interventional
Source Shenzhen TargetRx, Inc.
Contact Kai Yan
Phone 86-13754709367
Email kai.yan@tjrbiosciences.com
Status Recruiting
Phase Phase 1
Start date March 29, 2021
Completion date June 30, 2025

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