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

TGRX-678-2001

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

2024-06-15

2026-07-15

2027-12-15

Not yet recruiting

Early phase I

40

Inclusion Criteria: * Willing to consent * 18 years of age or above at time of screening; both sexes eligible * Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment * For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI * For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment * Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests * ECOG score \</=2 * Minimum life expectancy of at least 3 months * Adequate hematological indicators * Adequate kidney function * Adequate liver function * Adequate coagulation function * Adequate pancreatic 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 presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose * Reception of other anti-tumor treatments * In need for immune suppressive treatment * Usage of drugs associated with Torsades de Pointes within 1 months before screening * Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug * History of hemapoietic stem cell transplant * Presence of active central nervous system conditions * CML-AP patients who already reached major hematological response * CML-AP patients who used to progress to Blast Phase (BP) * Presence or having uncontrolled condition for cardiovascular diseases * History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening) * Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose * Severe hemorrhagic disease unrelated to CML * History of severe cardiovascular condition during past TKI treatment for CML * History of pancreatic inflammation or alcohol abuse within 3 years before first dose * Uncontrolled Hypertriglyceridemia * Presence of malabsorption or other conditions that may affect drug absorption * Diagnosis of other primary malignant tumor within 5 years * Reception of major surgery 14 days before first dose * Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C) * Presence of other conditions that the investigators or medical monitor deem unfit for the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-06-12