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

Launched by SHENZHEN TARGETRX, INC. · Jun 5, 2024

Keywords

ClinConnect Summary

The TGRX-678 clinical trial is studying a new treatment called TGRX-678 for patients with Chronic Myelogenous Leukemia (CML) who are in an Accelerated Phase and have not responded to previous treatments using third-generation Tyrosine Kinase Inhibitors (TKIs). This trial aims to see how safe and effective TGRX-678 is for these patients. The study is currently looking for participants aged 18 and older, regardless of gender, who have experienced a relapse or have not responded to TKI therapies. To qualify, patients must have a specific diagnosis of CML-AP and meet certain health criteria, including having adequate function in their blood, kidneys, and liver.

If you join this trial, you will receive the investigational treatment and be closely monitored by healthcare professionals throughout the study. Participants need to agree to use contraceptive measures if they are of childbearing potential, and they will undergo tests to ensure they meet eligibility requirements before starting the treatment. It’s important to know that there are specific conditions and recent treatments that may disqualify you from participating, so discussing your medical history with the research team is essential.

Gender

ALL

Eligibility criteria

• 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