RecruitingPhase 1NCT06088888

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

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


Sponsor

Shenzhen TargetRx Co., Ltd.

Enrollment

90 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral drug called TGRX-678 for people with chronic myelogenous leukemia (CML) — a type of blood cancer — that has not responded to or cannot be tolerated with existing targeted treatments (called TKIs, or tyrosine kinase inhibitors). The study aims to find the right dose and assess safety. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CML in the chronic phase - Your cancer has become resistant to or you cannot tolerate TKI treatments - Your organ function (kidneys, liver, bone marrow) is within acceptable limits - Your heart rhythm (QT interval) is normal on an ECG - If female, you must have a negative pregnancy test and use effective contraception **You may NOT be eligible if...** - You are currently receiving or recently received another anti-cancer therapy - You are in the accelerated or blast phase of CML - You have serious heart rhythm problems - You are pregnant or breastfeeding - You have participated in another clinical trial recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTGRX-678

Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as pre-determined for the dose escalation sequence or expansion cohorts.


Locations(2)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06088888


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