NCT07489755

TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients

A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs

Detailed description

This Phase III study is of randomized, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-CP patients. Patients need to have medical history of failing treatment(s) from at least 3 TKI drugs. Patients with or without T315I mutation is enrolled. Patients are randomized to either TGRX-678 treatment or TKI treatment at investigator's decision.

Conditions

• Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia - Chronic Phase

Interventions

Type	Name	Description
DRUG	TGRX-678	Patients will be given TGRX-678 for oral administration
DRUG	TKI	Patient will take TKI of investigator's choice for oral administration

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-05-01
• Completion: 2031-05-01
• First posted: 2026-03-24
• Last updated: 2026-03-24