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TGRX-678 US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

Chronic Myelogenous Leukemia Clinical Trial

Official title:
A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

Clinical Trial Summary

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate 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 trial with TGRX-678 conducted to US patients which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerance to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the recommended dose for expansion (RDE) 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 and molecular markers. Recommended Phase II dose (RP2D) will be determined at end of the study considering safety, tolerability, pharmacokinetic and efficacy data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06088888
Study type Interventional
Source Shenzhen TargetRx, Inc.
Contact Xinyi Zhu
Phone 86-13061651609
Email xinyi.zhu@tjrbiosciences.com
Status Recruiting
Phase Phase 1
Start date June 15, 2024
Completion date June 30, 2027
View Details
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