NCT06453902

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

A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment

Detailed description

This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.

Conditions

• Chronic Myeloid Leukemia
• Accelerated Phase CML

Interventions

Type	Name	Description
DRUG	TGRX-678	All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally

Timeline

• Start date: 2024-07-15
• Primary completion: 2026-06-30
• Completion: 2028-04-30
• First posted: 2024-06-12
• Last updated: 2025-02-21

Locations

1 site across 1 country: China