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Trial Title:
TGRX-678 US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia
NCT ID:
NCT06088888
Condition:
Chronic Myelogenous Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TGRX-678
Description:
Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as
pre-determined for the dose escalation sequence or expansion cohorts.
Arm group label:
TGRX-678
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.
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 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.
Criteria for eligibility:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elias Jabbour, MD
Phone:
713-792-4764
Email:
ejabbour@mdanderson.org
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Oehler, MD
Phone:
206-667-1340
Email:
voehler@fredhutch.org
Start date:
June 15, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Shenzhen TargetRx, Inc.
Agency class:
Industry
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
Shenzhen TargetRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06088888
