Oncolytic virus VG161 in refractory hepatocellular carcinoma.
Yinan Shen, Xueli Bai, Qi Zhang...
https://pubmed.ncbi.nlm.nih.gov/40108464Actively Recruiting
Phase 1
Age: 18Years - 75Years
All Genders
ID04806464
Dose Ascending Open Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Effectiveness of VG161 in Advanced Primary Liver Cancer
Led by CNBG-Virogin Biotech (Shanghai) Ltd. · Updated on 2024-09-19
44
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG161, a recombinant human IL12/15/PDL1B oncolytic HSV-1 injectable drug, in adults with advanced primary liver cancer who have not responded to standard treatments. This open-label Phase 1 study aims to assess the safety, tolerability, and preliminary effectiveness of VG161 in subjects who are HSV-seropositive. The study is divided into two parts: an initial dose-escalation phase followed by an extended dose evaluation phase. In Part 1, participants receive VG161 in ascending doses through intratumoral injections administered on Day 1 or over multiple days up to Day 3, with doses ranging from 1.0×10^8 to 1.7×10^8 PFU. This part includes accelerated titration and dose escalation cohorts to determine the maximum tolerated dose and recommended dose. Part 2 involves treatment at the recommended dose identified in Part 1 to further evaluate effectiveness and safety. Participants will be monitored for adverse events, dose-limiting toxicities, and immune response markers over periods up to 7 months, with survival rates assessed up to 17 months. Evaluations include clinical exams, laboratory tests, and imaging to assess tumor response and immune parameters. Ongoing safety and pharmacokinetics assessments are conducted throughout the study duration, providing comprehensive data on VG161's impact in this patient population.
CONDITIONS
Brief Title
Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or combined hepatocellular carcinoma that is refractory, relapsed, or intolerant to standard therapies
- Tumor lesions intrahepatic and/or with extrahepatic metastases that can be injected under ultrasound and meet size requirements (longest diameter >1.5 cm or short diameter for lymph nodes)
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function including hematology, liver, renal, and coagulation parameters within specified limits
- Negative HBV-DNA or receiving appropriate treatment for HBV infection
- Agreement to use reliable contraception during the study and for 90 days after last dose if of childbearing potential
- Signed informed consent form
You will not qualify if you...
- Prior anti-tumor therapies (chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy) within 4 weeks before study treatment, except oral fluorouracil analogues and small molecule targeted drugs which require 2 weeks or 5 half-lives washout
- Transcatheter arterial chemoembolization (TACE) within 4 weeks before study treatment
- Participation in other investigational drug trials within 4 weeks before study treatment
- Major organ surgery or significant trauma within 4 weeks before study treatment
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive medications within 14 days before study treatment
- Any grade 1 or higher toxicity related to prior anti-cancer therapy except alopecia
- Presence of central nervous system or meningeal metastasis
- Seronegative for HSV (HSV-1 IgG and IgM)
- History or relapse of HSV infection with clinical symptoms
- Other uncontrolled active infections
- HIV infection or known immunodeficiency
- Severe cardiovascular disease including arrhythmias, QTc >480 ms, recent acute coronary events, heart failure grade II or above, uncontrolled hypertension
- Active or relapsing autoimmune diseases except stable autoimmune thyroiditis
- Prior immunotherapy causing immune-related adverse events affecting safety
- Alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnancy or breastfeeding
- Any significant unrelated systemic illness compromising eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 7 months
Participants receive intratumoral injections of VG161 on Day 1 or Days 1 through 5 in dose-escalating cohorts to assess safety and tolerability.
Multiple visits during dosing and follow-up assessments
Follow-up
Duration - Up to 17 months
Participants are monitored for safety, treatment response, and long-term outcomes after completion of VG161 treatment.
Periodic visits up to 17 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
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Research Team
T
Tingbo Liang, MD.PhD.
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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