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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia - Chronic Phase
• Intervention / Treatment: Drug: TGRX-678; Drug: TKI

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willing to consent and to follow study procedures
• 18 years of age or above at time of screening; both sexes eligible
• Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments
• ECOG score >= 2
• Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)
• Adequate kidney, liver and coagulation function
• Adequate QTc interval as confirmed by electrocardiogram (ECG) test
• Negative pregnancy result at screening for female patients of child-bearing potential
• Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)

Exclusion Criteria:

• Reception of TKI treatment or other anti-tumor treatments prior to first dose
• History or presence of extramedullary leukemia
• History of progression to CML-AP or BP
• Presence or having uncontrolled condition for cardiovascular diseases
• History of severe hemorrhagic disease
• Presence of malabsorption or other conditions that may affect drug absorption
• History of other primary malignancy within 5 years
• Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
• In need for or having long-term immune suppressive treatment
• Reception of major surgery 28 days before first dose
• Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade >=1
• Presence of other conditions that the investigators or medical monitor deem unfit for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TGRX-678; Patients randomly assigned to this arm will take TGRX-678 as treatment for CML	Drug: TGRX-678; Patients will be given TGRX-678 for oral administration
Active Comparator: TKI; Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML	Drug: TKI; Patient will take TKI of investigator's choice for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	EFS measures time duration between randomization to disease progression, treatment failure, loss of efficacy, development of new mutation, or death, whichever occurs first	from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematologic Response	Rate of occurence of complete hematologic response (CHR).	From randomization to end of study (estimated study duration: 5 years)
Cytogenetic Response	Rate of occurence of Major Cytogenetic Response (MCyR) and Complete Cytogenetic Response (CCyR).	from randomization to end of study (estimated study duration: 5 years)
Molecular Response	Rate of Occurence for Major Molecular Response (MMR)	from randomization to end of study (estimated study duration: 5 years)
Progression Free Survival (PFS)	Duration between enrollment to progressive disease or death of any cause	from randomization to end of study (estimated study duration: 5 years)
Overall Survival (OS)	Duration between enrollment to death of any cause	from randomization to end of study (estimated study duration: 5 years)
Treatment Emergent Adverse Event (TEAE)	To record and analyse the occurence and frequency of adverse events during the study	from randomization to end of study (estimated study duration: 5 years)

Collaborators and Investigators

• Sponsor: Shenzhen TargetRx Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: TGRX-678-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No