Status:
RECRUITING
TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies
Lead Sponsor:
Shenzhen TargetRx, Inc.
Collaborating Sponsors:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Hematologic Malignancy
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this single- arm, open-label, dose escalation and dose expansion phase I/II study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patien...
Detailed Description
This is the first-in-human trial with TGRX-814 which aims to evaluate the safety, pharmacokinetic and preliminary efficacy profiles with hematological malignancies. The primary purpose of this study i...
Eligibility Criteria
Inclusion
- male or female ≥ 18 years of age
- fully understand the requirements of the study and voluntarily sign a written informed consent form
- diagnosis of NHL, ALL, AML or MDS
- Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2
- adequate bone marrow function
- patients at high risk for Tumor Lysis Syndrome (TLS) determined by investigator and sponsor for agreement to enroll
- adequate disease indicator
- adequate coagulation, hepatic and renal function
- female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use a medically approved highly effective contraceptive from the time of signing the Informed Consent Form until at least 3 months after the last dose of study drug; women of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug
- Expected survival time ≥ 12 weeks
Exclusion
- received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance
- subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma/leukemia, or post-transplant lymphoproliferative disease (PTLD)
- AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia
- tumor infiltration of the central nervous system
- received allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months
- received vaccination within 4 weeks prior to first dose or scheduled to be vaccinated during the study
- HBsAg-positive or HBcAb-positive; HCV antibody-positive; HIV antibody-positive
- monoclonal antibody antitumor therapy within 4 weeks prior to the first dose; participation in a clinical trial of another interventional drug within 4 weeks prior to the first dose; participation in CAR-T therapy within 12 weeks prior to the first dose; 9. 14 weeks prior to the first dose
- received anticancer therapy/investigational therapy within 14 days prior to the first dose, or has not recovered from clinically significant toxicity below grade 2 on prior therapy
- received steroidal anticancer therapy, CYP3A inhibitors, or CYP3A inducers within 7 days prior to the first dose of study drug
- consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or popcorn within 3 days prior to the first dose of the drug
- poorly controlled hypertension; left ventricular ejection fraction ≤ 50% as assessed by cardiac ultrasound; prolonged QT interval; Grade III atrioventricular block or other arrhythmia requiring medical intervention; New York Heart Association (NYHA) Class III or IV congestive heart failure; had myocardial infarction or experienced bypass surgery within 6 months prior to dosing; had arterial or venous thrombotic events within 6 months prior to the first dose of study drug; have other cardiovascular diseases that investigator deemed unfit for enrollment
- having a history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect the subject's participation in this study
- having a history of active malignancy other than NHL, AML, or MDS within 3 years prior to participation in this clinical study
- having a condition of malabsorption syndrome or multiple factors that interfere with the oral administration and absorption of medication
- other uncontrolled conditions of clinical significance
- other factors that, in the opinion of the Investigator, may affect the results of the study and interfere with the patient's participation in the study, including previous or existing medical conditions, abnormalities in treatment or laboratory tests, unwillingness of the subject to comply with the procedures, restrictions and requirements of the study, and other conditions that make enrollment in the study unsuitable.
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06206174
Start Date
March 6 2024
End Date
February 28 2029
Last Update
April 10 2024
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020