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

NCT07489755 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TGRX-678-3001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia - Chronic Phase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hematologic Response

  From randomization to end of study (estimated study duration: 5 years)

• Cytogenetic Response

  from randomization to end of study (estimated study duration: 5 years)

• Molecular Response

  from randomization to end of study (estimated study duration: 5 years)

• Progression Free Survival (PFS)

  from randomization to end of study (estimated study duration: 5 years)

• Overall Survival (OS)

  from randomization to end of study (estimated study duration: 5 years)

Study Arms (2)

TGRX-678

EXPERIMENTAL

Patients randomly assigned to this arm will take TGRX-678 as treatment for CML

Drug: TGRX-678

TKI

ACTIVE COMPARATOR

Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML

Drug: TKI

Interventions

TGRX-678 DRUG

Patients will be given TGRX-678 for oral administration

TGRX-678

TKI DRUG

Patient will take TKI of investigator's choice for oral administration

TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to consent and to follow study procedures
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen TargetRx Co., Ltd.: lead

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share