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

• Status: Recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen TargetRx, Inc.
• Collaborator: M.D. Anderson Cancer Center

Criteria

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;