A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
Shenzhen TargetRx Co., Ltd.
Summary
The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.
Description
This is the first trial with TGRX-678 conducted to US patients which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerance to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the recommended dose for expansion (RDE) and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678 is evaluated based on the changes in peripheral blood cells and dis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing to participate in the study with informed consent; * At least 18 years of age at the time of screening; * Any sex; * Diagnosis of CML-CPduring the screening period; * Intolerant or resistant to TKI treatments; * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels; * Adequate renal and liver function; * Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results; * Negative blood pregnancy test results for female patients of childbearing pote…
Interventions
- DrugTGRX-678
Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as pre-determined for the dose escalation sequence or expansion cohorts.
Locations (2)
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Fred Hutchinson Cancer CenterSeattle, Washington