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

Active: Yes
Cancer Type: Leukemia NCT ID: NCT06088888
Trial Phases: Phase I Protocol IDs: TGRX-678-07-101 (primary)
NCI-2023-10579
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Shenzhen TargetRx, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT06088888

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.