Tests TGRX-678 in people with leukemia that returned after newer treatment

Trial details

Who runs it

Shenzhen TargetRx Co., Ltd.

Trial code

NCT06453902

Record updated

21 February 2025

Original description

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) treatmentRead full original descriptionShow less

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

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

Inclusion: 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: 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 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; Reception of major surgery 14 days before first dose; History of hemapoietic stem cell transplant; Presence of active central nervous system conditions; Presence or having uncontrolled condition for cardiovascular diseases; 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; Presence of malabsorption or other conditions that may affect drug absorption; Diagnosis of other primary malignant tumor within 5 years; 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; 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; CML-AP patients who already reached major hematological response; CML-AP patients who used to progress to Blast Phase (BP); Uncontrolled Hypertriglyceridemia.

ClinicalTrials.gov NCT06453902