OncoMatch/Clinical Trials/NCT04806464
Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
Is NCT04806464 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 for primary liver cancer.
Treatment: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 — VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This phase I study will be conducted in HSV-seropositive subjects with advanced primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts. Part 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161. Part 2: This part is extended dose design to determine the effectiveness of VG161.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: standard therapies
refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists
Cannot have received: anti-tumor therapies (chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy)
Exception: oral fluorouracil analogues and small molecule targeted drugs: 2 weeks prior to first dose or within 5 half-lives (whichever longer)
prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation
Cannot have received: transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization(TACE) within 4 weeks of study treatment initiation
Cannot have received: investigational agents
Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation
Lab requirements
Blood counts
ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥85g/L
Kidney function
Serum creatinine≤1.5×ULN, and creatinine clearance≥45 ml/min (Cockcroft-Gault)
Liver function
Total Serum bilirubin (TBIL)≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN; Child-Pugh A-B level
Cardiac function
QTc interval >480 ms, LVEF <50%, NYHA cardiac function grade≥II, acute coronary syndrome, CHF, stroke or other cardiovascular events of III grade or above within 6 months, uncontrolled hypertension
Required organ function: ... Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): absolute neutrophil count (ANC)≥1.5×10^9L, platelets (PLT)≥75×10^9L, hemoglobin (Hb)≥85g/L; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤5×ULN, aspartate aminotransferase (AST)≤5×ULN; 3)Child-Pugh A-B level; 4) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥45 ml/min (calculated per Cockcroft-Gault formula); 5) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, prothrombin time(PT) ≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04806464 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-tumor therapies (chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy), transcatheter arterial chemoembolization, investigational agents disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages