Actively Recruiting
TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies
Led by Shenzhen TargetRx Co., Ltd. · Updated on 2024-04-10
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Shenzhen TargetRx Co., Ltd.
Lead Sponsor
I
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.
CONDITIONS
Official Title
TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Able to fully understand study requirements and provide written informed consent
- Diagnosed with non-Hodgkin lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndromes
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or less
- Adequate bone marrow function
- At high risk for Tumor Lysis Syndrome as determined by investigator and sponsor
- Adequate disease indicator
- Adequate coagulation, liver, and kidney function
- Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to use highly effective contraception during and for 3 months after treatment; females must have a negative pregnancy test within 7 days before first dose
- Expected survival time of at least 12 weeks
You will not qualify if you...
- Prior BCL-2 inhibitor therapy unless stopped due to intolerance
- Diagnosis of Burkitt's lymphoma, lymphoblastoid lymphoma/leukemia, or post-transplant lymphoproliferative disease in non-Hodgkin lymphoma patients
- Diagnosis of acute promyelocytic leukemia, Philadelphia chromosome positive leukemia, or persistent extramedullary leukemia in acute myeloid leukemia patients
- Tumor infiltration of the central nervous system
- Received allogeneic stem cell transplant or autologous transplant within 3 months
- Vaccination within 4 weeks before first dose or planned vaccination during study
- Positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibody
- Monoclonal antibody therapy within 4 weeks before first dose, participation in another drug clinical trial within 4 weeks, or CAR-T therapy within 12 weeks before first dose
- Anticancer or investigational therapy within 14 days before first dose or incomplete recovery from prior treatment toxicity
- Steroidal anticancer therapy or CYP3A inhibitors/inducers within 7 days before first dose
- Consumption of grapefruit, Seville oranges, or related products within 3 days before first dose
- Poorly controlled high blood pressure, heart issues including low left ventricular ejection fraction, prolonged QT interval, severe arrhythmias, severe heart failure, recent heart attack or bypass surgery, recent blood clots, or other significant cardiovascular diseases
- History of kidney, neurological, psychiatric, lung, endocrine, metabolic, immune, heart, or liver diseases affecting study participation
- History of active cancers other than the eligible types within 3 years
- Conditions affecting oral medication absorption
- Other uncontrolled significant medical conditions
- Any other factors judged by the investigator to interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
K
Kai Yan
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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