The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
NCT Number: NCT07522476
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Hangzhou, Zhejiang, 310003, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recommended Phase II Dose, Intratumoral Injection, Q4W
Time frame: up to 36 months
Objective response rate (ORR)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 36 months
Progression-free survival (PFS)
Time frame: up to 36 months
Overall Survival (OS)
Time frame: up to 36 months
Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels
Time frame: up to 36 months
Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators
Time frame: up to 36 months
Safety will be evaluated according to CTCAE 6.0, including AEs/SAEs during the study, abnormalities or changes in 12-lead ECGs, and laboratory tests.
Contact information is provided by the study sponsor or research team.
Virogin Biotech Ltd.
Industry
An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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