TGRX-678 US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia
18 Years and older, Male and Female
TGRX-678-07-101 (primary)
NCI-2023-10579
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.
Objectives
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 or intolerance to TKI treatments. The primary purpose of this study
is to evaluate the safety profile of TGRX-678, including determination of the recommended
dose for expansion (RDE) and other safety measures of the investigational drug, such as
adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678
is evaluated based on the changes in peripheral blood cells and disease-associated
cytogenetic and molecular markers. Recommended Phase II dose (RP2D) will be determined at
end of the study considering safety, tolerability, pharmacokinetic and efficacy data.
Eligibility
- 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.
Treatment Sites in Georgia
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