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Tests treatment safety and results for Hepatocellular Carcinoma
Official title A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06326502
What this study is testing
What is ETN101?
ETN101 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male and female adult at the age of ≥ 19 years old
- Patients with radiologically or histologically, and/or cytologically confirmed advanced HCC who have confirmed disease progression on standard...
- Subject with Barcelona Clinic Liver Cancer (BCLC) stage B or C; Subject with Stage B must have had progressive disease (PD) after radical resection...
- Subject with Child-Pugh score A (5-6)
- Subject who has at least one measurable target lesion based on modified RECIST (mRECIST) which was not previously treated with local therapy. A...
You likely can't join if
- Individual with severe drug sensitivity or sensitivity reactions to IP and any of its components or drugs in similar classes
- Individual with a confirmed disease which makes oral drug administration difficult or which affects the absorption of orally administered drugs...
- Individual with any of the following past medical history or surgical/procedure history:
- History of other primary cancer within 3 years from screening (However, individuals who had skin basal cell carcinoma/squamous cell carcinoma, local...
- Hepatic radiation, chemoembolization, or radiofrequency ablation within 4 weeks prior to IP administration
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to IP administration
See the full eligibility criteria
Who can join
- Male and female adult at the age of ≥ 19 years old
- Patients with radiologically or histologically, and/or cytologically confirmed advanced HCC who have confirmed disease progression on standard therapies known to have clinical benefit or for whom there is no currently...
- Subject with Barcelona Clinic Liver Cancer (BCLC) stage B or C; Subject with Stage B must have had progressive disease (PD) after radical resection, liver transplant, embolization, or cauterization or must be ineligible...
- Subject with Child-Pugh score A (5-6)
- Subject who has at least one measurable target lesion based on modified RECIST (mRECIST) which was not previously treated with local therapy. A lesion previously treated with local therapy may be selected as a target...
- Subject with Eastern Cooperative Oncology Group (ECOG) status performance 0-1.
- Subject with ≥ 12 weeks of life expectancy
- Subject who meets the following criteria for laboratory tests (Subject must not have been treated with granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 14 days prior to the laboratory tests.):
- Hematology
- Absolute neutrophil count(ANC) ≥1,500/mm3
- Platelet count ≥60,000/mm3
- Hemoglobin(Hb) ≥8.5 g/dL
- Kidney function: Serum creatinine ≤1.5 × upper limit of normal(ULN)
- Liver function
- Aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤5 × ULN
- Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for Gilbert's disease)
- Blood coagulation function: Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN
- Subject who voluntarily agrees to participate in the study and signs the informed consent form (ICF) after being fully informed of the study
What rules you out
- Individual with severe drug sensitivity or sensitivity reactions to IP and any of its components or drugs in similar classes
- Individual with a confirmed disease which makes oral drug administration difficult or which affects the absorption of orally administered drugs (celiac disease, Crohn's disease, or enterectomy affecting absorption, etc.)
- Individual with any of the following past medical history or surgical/procedure history:
- History of other primary cancer within 3 years from screening (However, individuals who had skin basal cell carcinoma/squamous cell carcinoma, local prostate cancer, papillary thyroid cancer, or cervical intraepithelial...
- Hepatic radiation, chemoembolization, or radiofrequency ablation within 4 weeks prior to IP administration
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to IP administration
- Clinically significant arrhythmia, acute myocardial infarction, unstable angina pectoris, or New York Heart Association (NYHA) Ⅲ or Ⅳ heart failure within 6 months prior to IP administration
- Severe cerebrovascular disease within 6 months prior to IP administration
- Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma or obstructive pulmonary disease that is considered ineligible for study participation, or other life-threatening severe pulmonary disease (e.g., acute...
- Individual with any of the following diseases:
- Clinically significantly symptomatic or uncontrolled central nervous system or brain metastasis (However, individuals who have been stable for ≥ 4 weeks based on repeated imaging and clinical observations, as confirmed...
- Clinically significant electrocardiogram (ECG) abnormalities based on the judgment of the investigator
- Uncontrolled hypertension (systolic blood pressure [BP] \>140 mmHg or diastolic BP \>90 mmHg)
- Grade ≥ 3 active infectious disease requiring treatment. However, individuals with hepatitis B and hepatitis C may be enrolled if replication activity is undetectable (HBV DNA below the limit of detection) and antiviral...
- Active autoimmune disease requiring systemic treatment
- Known human immunodeficiency virus (HIV) infection
- Symptomatic ascites or pleural effusion (However, patients who are treated and clinically stabilized may be enrolled.)
- Grade ≥ 3(≥3.5 g/24 h) proteinuria
- Any disease that may affect the interpretation of study results based on the judgment of the investigator
- Individuals who have any of the following history of medication or treatment:
- Anticancer therapy [chemotherapy, hormone therapy, targeted therapy, or radiotherapy, etc.] within 4 weeks prior to IP administration
- Live attenuated vaccines within 4 weeks prior to IP administration
- Strong CYP1A2 inhibitors within 2 weeks prior to IP administration
- Prior allogeneic bone marrow or solid organ transplantation
- Pregnant or lactating woman, or man or woman of childbearing potential who is unwilling to practice abstinence or to use adequate methods of contraception\ from after study enrollment to at least 6 months (in female...
- Hormonal contraception (subdermal contraceptive implants, injections, oral contraceptives)
- Insertion of intrauterine device or intrauterine system
- Subject's or spouse (partner)'s surgical sterilization (vasectomy, tubal ligation, etc.)
- Individual with prior chemotherapy related toxicity not recovered to Grade ≤ 1 or baseline level (with the exception of alopecia)
- Individual who is unable to undergo contrast-enhanced CT or MRI
- Individual who was treated with another IP or investigational device within 4 weeks prior to IP administration in the present study
- Patient who is ineligible or unable to participate in the study for other reasons based on the judgment of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.