Status:
RECRUITING
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
Lead Sponsor:
Shenzhen TargetRx, Inc.
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Myelogenou...
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06088888
Start Date
July 2 2024
End Date
June 30 2027
Last Update
February 21 2025
Active Locations (2)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98102