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

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;