Actively Recruiting
Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
Led by CNBG-Virogin Biotech (Shanghai) Ltd. · Updated on 2024-09-19
44
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 18 to 75 years
- Diagnosed with advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or combined hepatocellular carcinoma that is refractory, relapsed, or intolerant to standard therapies, or no standard therapy exists
- For Part 2, only advanced primary hepatocellular carcinoma patients will be enrolled
- Have intrahepatic and/or extrahepatic tumor lesions suitable for ultrasound-guided injection, with lesion size >1.5 cm in longest diameter or lymph node shortest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months
- Adequate blood, liver, renal, and coagulation function based on specific laboratory values
- Negative HBV-DNA or HBV-DNA positive patients receiving treatment per clinical guidelines
- Females of childbearing potential must have a negative pregnancy test and agree to use reliable contraception during the study and 90 days after last dose
- Signed informed consent
You will not qualify if you...
- Received anti-tumor therapies (chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy) within 4 weeks prior to study treatment, except specified allowances for oral fluorouracil analogues and small molecule targeted drugs
- Underwent transcatheter arterial chemoembolization (TACE) within 4 weeks prior to study treatment
- Participated in other investigational drug trials within 4 weeks prior to study treatment
- Had major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to study treatment
- Received systemic corticosteroids (>10 mg prednisone daily or equivalent) or other immunosuppressives within 14 days prior to study treatment
- Have any grade ≥1 toxicity from prior anti-cancer therapy except alopecia
- Have central nervous system or meningeal metastases
- HSV seronegative or active HSV infection with clinical symptoms
- Have uncontrolled active infections or known HIV infection
- History of severe cardiovascular disease including ventricular arrhythmias, QTc >480 ms, recent acute coronary events, heart failure with LVEF <50%, or uncontrolled hypertension
- Active or past autoimmune diseases likely to recur, except stable autoimmune thyroiditis
- Previous immunotherapy with immune-related adverse events that may compromise safety
- Known alcohol or drug dependence
- Have mental disorders or poor compliance
- Pregnant or breastfeeding women
- Any other significant systemic illness compromising eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Tingbo Liang, MD.PhD.
CONTACT
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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