A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma

NCT06326502 | Recruiting Phase 1 DMC

• 1 other identifier: 22ETN101-2IND001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Liver Cancer

Keywords

HCC

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity (DLT)

  DLT will be monitored during Cycle 1 (3 weeks) starting from the start date of intraperitoneal (IP) dosing

  Up to 3 weeks after start of injection

Study Arms (1)

ETN101

EXPERIMENTAL

ETN101

Drug: ETN101

Interventions

ETN101 DRUG

Oral administration

ETN101

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 therapies known to have clinical benefit or for whom there is no currently available standard therapy due to intolerance or incompatibility.
• 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 for such treatment.
• 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 lesion if an increase of ≥20% in size is confirmed after treatment.
• 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

You may not qualify 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 (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 neoplasia within 3 years may participate in the study if it is confirmed by the investigator to have been cured following successful treatment.)
• 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 respiratory distress syndrome, lung failure) within 6 months prior to IP administration
• 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 by clinical and imaging tests during the screening period, may participate in the study.)
• 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 treatment against hepatitis C is not required, respectively.
• Active autoimmune disease requiring systemic treatment

Sponsors & Collaborators

• Etnova Therapeutics Corp.: lead

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• Park HJ, Choi G, Ha S, Kim Y, Choi MJ, Kim M, Islam MK, Chang Y, Kwon TJ, Kim D, Jang E, Kim TH, Chang SJ, Kim YH. MBP-11901 Inhibits Tumor Growth of Hepatocellular Carcinoma through Multitargeted Inhibition of Receptor Tyrosine Kinases. Cancers (Basel). 2022 Apr 14;14(8):1994. doi: 10.3390/cancers14081994.

  PMID: 35454900 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yeonhee Kim, Ph.D

  Etnova Therapeutics

  STUDY DIRECTOR

Central Study Contacts

HyeJin Yang, Ph.D

CONTACT

82-10-2573-1857; hjyang@etnova.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): June 7, 2027
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

KR (2)