MBP-11901 Inhibits Tumor Growth of Hepatocellular Carcinoma through Multitargeted Inhibition of Receptor Tyrosine Kinases.
Hyun Jin Park, Garam Choi, Seongmin Ha...
https://pubmed.ncbi.nlm.nih.gov/35454900Actively Recruiting
Phase 1
Age: 19Years - 65Years
All Genders
Healthy Volunteers
ID06326502
An Open-label, Multi-center, Dose-escalation Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ETN101 in Patients With Advanced Hepatocellular Carcinoma
Led by Etnova Therapeutics Corp. · Updated on 2024-03-27
50
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ETN101, a multiple tyrosine kinase inhibitor (mTKI) designed to target specific receptors involved in cancer growth, including FLT3, KIT, VEGFR2, and PDGFR-beta. This investigational drug has shown promising anticancer effects in laboratory and animal studies, including cases where standard liver cancer treatments did not work. The study focuses on patients with advanced hepatocellular carcinoma (HCC) who have tried at least two prior anticancer therapies and are seeking new treatment options. The study involves oral administration of ETN101 to patients with advanced HCC. It is an open-label, multi-center, dose-escalation phase 1 trial aiming to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, and efficacy of ETN101. Patients will receive ETN101, and the study will monitor effects over a period of up to three weeks after starting treatment for dose-limiting toxicities. Participants will be evaluated through regular clinical assessments, laboratory tests, and imaging to measure tumor response and safety. The primary outcome is to observe any dose-limiting toxicities within three weeks of treatment. Patients must meet specific criteria related to liver function, tumor characteristics, and overall health status. This study may last until June 2027, with ongoing monitoring of safety and treatment effects during the trial.
CONDITIONS
Brief Title
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma
Who Can Participate
Age: 19Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosis of advanced hepatocellular carcinoma confirmed by imaging, histology, or cytology
- Disease progression after standard therapies, or no available standard therapy due to intolerance
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; stage B patients must have progressive disease after prior treatments or be ineligible for them
- Child-Pugh liver function score A (5-6)
- At least one measurable tumor lesion not previously treated locally, or with confirmed growth after local therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood counts, kidney function, liver function, and blood clotting parameters
- Signed informed consent form after full information about the study
You will not qualify if you...
- Severe drug allergies or reactions to ETN101 or similar drugs
- Conditions affecting oral drug absorption (e.g., celiac disease, Crohn's disease)
- History of other primary cancers within 3 years, except certain treated skin, prostate, thyroid, or cervical conditions
- Recent liver radiation, chemoembolization, or ablation within 4 weeks
- Recent major surgery within 4 weeks or minor surgery within 2 weeks
- Significant heart conditions or heart failure within 6 months
- Severe cerebrovascular disease within 6 months
- Recent severe lung diseases or blood clots within 6 months
- Uncontrolled brain metastases or significant ECG abnormalities
- Uncontrolled high blood pressure
- Active serious infections requiring treatment, except controlled hepatitis B or C
- Active autoimmune disease needing systemic treatment
- HIV infection
- Symptomatic ascites or pleural effusion unless stabilized
- Severe proteinuria (high protein in urine)
- Any disease affecting study result interpretation
- Recent anticancer treatment within 4 weeks
- Recent live attenuated vaccines within 4 weeks
- Recent strong CYP1A2 inhibitors within 2 weeks
- Prior bone marrow or organ transplant
- Pregnancy, breastfeeding, or unwillingness to use contraception as required
- Unresolved chemotherapy-related toxicity above grade 1 except hair loss
- Unable to undergo contrast-enhanced CT or MRI
- Treatment with other investigational drugs or devices within 4 weeks
- Other conditions making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 weeks for dose-limiting toxicity evaluation, with continued treatment as determined by study protocol
Participants receive the study drug ETN101 by oral administration to evaluate its safety, tolerability, and efficacy in advanced hepatocellular carcinoma.
Multiple visits during treatment as scheduled by the study team
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
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Research Team
H
HyeJin Yang, Ph.D
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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