Actively Recruiting
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
Led by Shenzhen TargetRx Co., Ltd. · Updated on 2025-02-21
90
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shenzhen TargetRx Co., Ltd.
Lead Sponsor
M
M.D. Anderson Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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-CP during the screening period
- Intolerant or resistant to TKI treatments
- Eastern Cooperative Oncology Group (ECOG) performance status 64 2
- Adequate absolute neutrophil count (ANC), hemoglobin and platelet levels
- Adequate renal and liver function
- Normal corrected QT (QTcF) interval as indicated by 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
You will not qualify if you...
- 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 less than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98102
Actively Recruiting
Research Team
X
Xinyi Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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