Actively Recruiting
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma
Led by Etnova Therapeutics Corp. · Updated on 2024-03-27
50
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents.
CONDITIONS
Official Title
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women aged 19 years or older
- Radiologically, histologically, or cytologically confirmed advanced hepatocellular carcinoma with disease progression on standard therapies or no available standard therapy
- Barcelona Clinic Liver Cancer stage B with progressive disease after treatment or ineligible for such treatments, or stage C
- Child-Pugh score of A (5-6)
- At least one measurable target lesion by modified RECIST not previously treated or showing at least 20% increase after local therapy
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Laboratory tests within specified limits for blood counts, kidney and liver function, and blood coagulation, without recent G-CSF or blood transfusions
- Voluntary informed consent to participate
You will not qualify if you...
- Severe drug allergy to the investigational product or similar drugs
- Diseases affecting oral drug administration or absorption (e.g., celiac disease, Crohn's disease, enterectomy)
- History of other primary cancers within 3 years except certain treated skin, prostate, thyroid, or cervical conditions
- Recent hepatic radiation, chemoembolization, or radiofrequency ablation within 4 weeks
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to study drug administration
- Significant heart conditions or cerebrovascular disease within 6 months
- Severe pulmonary diseases or thrombosis within 6 months
- Uncontrolled central nervous system metastasis or significant ECG abnormalities
- Uncontrolled hypertension
- Active severe infections, except controlled hepatitis B or C
- Active autoimmune disease needing systemic treatment
- HIV infection
- Symptomatic ascites or pleural effusion unless stabilized
- Severe proteinuria
- Any disease affecting study results interpretation
- Recent anticancer therapy, live vaccines, or strong CYP1A2 inhibitors
- Prior allogeneic bone marrow or organ transplantation
- Pregnancy, lactation, or unwillingness to use effective contraception
- Unresolved chemotherapy-related toxicity greater than grade 1 except alopecia
- Inability to undergo contrast-enhanced CT or MRI
- Participation in another investigational study within 4 weeks
- Any other reason deemed by investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
H
HyeJin Yang, Ph.D
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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