Actively Recruiting
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
Led by CNBG-Virogin Biotech (Shanghai) Ltd. · Updated on 2023-08-24
43
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts. Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination. Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.
CONDITIONS
Official Title
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before starting the trial
- Aged 18 to 75 years, any gender
- Diagnosed with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology
- Previously failed two or more systemic treatments including anti-PD-1 monoclonal antibodies or unable to continue treatment due to severe side effects
- Able to provide archived tumor tissue samples or willing to have a tumor biopsy before treatment
- Have at least one measurable tumor lesion suitable for injection, with lesion size greater than 1.5 cm
- Positive herpes simplex virus 1 antibody test (HSV-1 IgG or IgM)
- ECOG performance status score of 0 or 1
- Expected survival longer than 3 months
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters within specified limits
- Agree to use reliable contraception during the trial and for at least 90 days after last dose if of childbearing potential
- Female participants of childbearing age must have a negative pregnancy test before enrollment
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological or targeted therapy, immunotherapy, or other anti-tumor drugs within 4 weeks before study drug
- Taken unmarketed clinical trial treatments within 4 weeks before first dose
- Had major surgery or significant trauma within 4 weeks before first dose
- Used systemic corticosteroids or immunosuppressive agents within 14 days before first dose, except certain topical or inhaled steroids
- Received vaccination within 4 weeks prior to first dose
- Have unresolved adverse reactions from previous cancer treatments worse than grade 1 (except alopecia)
- Have central nervous system or spinal cord metastases or compression
- Have active diverticulitis or symptomatic gastrointestinal ulcers
- Currently have herpes simplex virus infection with symptoms or complications, or require ongoing antiviral treatment
- Have other active uncontrolled infections
- History of immunodeficiency, including positive HIV or syphilis tests
- Have active chronic hepatitis B or C, except stable or cured cases
- History of serious cardiovascular disease as detailed
- Have active or recurring autoimmune diseases that may flare, except certain stable autoimmune conditions
- Experienced serious immune-related adverse events from prior immunotherapy
- Have known alcohol or drug dependence
- Have mental disorders or poor compliance
- Are pregnant or breastfeeding
- Have fluid accumulation requiring clinical intervention
- Any other serious systemic diseases or conditions making them unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Lin Shen, Professor
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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