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.
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;
Exposure to other antineoplastic therapies prior to study enrollment;
Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy;
Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia);
Hematopoietic cell transplantation < 60 days prior to the first dose;
Shenzhen TargetRx Co., Ltd.
Lead sponsor
M.D. Anderson Cancer Center
Collaborator