OncoMatch/Clinical Trials/NCT06326502
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma
Is NCT06326502 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ETN101 for hepatocellular carcinoma.
Treatment: ETN101 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE B, BCLC STAGE C (BCLC)
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapies known to have clinical benefit — advanced HCC
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
Cannot have received: anticancer therapy
Anticancer therapy [chemotherapy, hormone therapy, targeted therapy, or radiotherapy, etc.] within 4 weeks prior to IP administration
Cannot have received: hepatic radiation, chemoembolization, or radiofrequency ablation
Hepatic radiation, chemoembolization, or radiofrequency ablation within 4 weeks prior to IP administration
Cannot have received: major surgery
Major surgery within 4 weeks or minor surgery within 2 weeks prior to IP administration
Cannot have received: live attenuated vaccines
Live attenuated vaccines within 4 weeks prior to IP administration
Cannot have received: strong CYP1A2 inhibitors
Strong CYP1A2 inhibitors within 2 weeks prior to IP administration
Cannot have received: allogeneic bone marrow or solid organ transplantation
Prior allogeneic bone marrow or solid organ transplantation
Cannot have received: investigational product or device
treated with another IP or investigational device within 4 weeks prior to IP administration in the present study
Lab requirements
Blood counts
ANC ≥1,500/mm3; Platelet count ≥60,000/mm3; Hemoglobin ≥8.5 g/dL
Kidney function
Serum creatinine ≤1.5 × ULN
Liver function
AST and ALT ≤5 × ULN; Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for Gilbert's disease); Child-Pugh score A (5-6)
Subject who meets the following criteria for laboratory tests ... Hematology: ANC ≥1,500/mm3, Platelet count ≥60,000/mm3, Hemoglobin ≥8.5 g/dL; Kidney function: Serum creatinine ≤1.5 × ULN; Liver function: AST and ALT ≤5 × ULN, Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for Gilbert's disease); Blood coagulation function: PT/INR and aPTT ≤1.5 × ULN; Child-Pugh score A (5-6)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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