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RecruitingPhase 2NCT06453902

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

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

Sponsor

Shenzhen TargetRx, Inc.

Enrollment

40 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid LeukemiaAccelerated Phase CML

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria16

  • Willing to consent
  • 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 Criteria21

  • 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

Interventions

DRUGTGRX-678

All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally

Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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