TGRX-678 US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

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 potential. Willing to take highly effective contraceptive measures throughout the trial and for 6 months after last dose of investigational drug for female subjects of child-bearing potential or male subject with female partner of child-bearing potential. Exclusion Criteria: 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; Evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy; Concomitant immunosuppressive therapy (other than short-term corticosteroid treatment); Exposure to drugs related to torsade de pointes; Cytological or pathological diagnosis of active central nervous system disorder; Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol; Having long QT syndrome, or with family history of idiopathic sudden death or congenital long QT syndrome; Uncontrolled hypertension; Receipt of Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes within 2 weeks prior to the first dose; Severe hemorrhagic disorders unrelated to CML; History of pancreatitis; History of excessive alcohol use; History of elevation in amylase or lipase within 1 year; Have Grade 2 or worse interstitial lung disease or interstitial pneumonitis within 4 weeks prior to Screening; Uncontrolled hypertriglyceridemia; Malabsorption syndrome or other illness that could affect oral absorption. Diagnosis of another primary malignancy in the past 3 years; Reception of major surgery within 14 days prior to the first dose; Active infections that require systemic treatment or other severe infections within 14 days prior to enrollment; Known human immunodeficiency virus (HIV) positive; acute or chronic liver disease (including chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections); Have received or will receive a COVID-19 vaccine within 14 days of study enrollment; Have a positive reverse transcriptase polymerase chain reaction (RT-PCR) test result for SARS-CoV-2 within 2 weeks prior to Screening; Pregnant or breastfeeding female; Female patient of child-bearing potential or male patient who have female partners of child-bearing potential that is unable or unwilling to take highly effective contraceptive measures during the trial and for 6 months after last dose of investigational drug; Significant organ dysfunction that could compromise the patient's safety or the evaluation of the drug's safety in the opinion of the investigator or the medical monitor; Any condition makes participation in this trial inappropriate in the opinion of the investigator or medical monitor;