NCT07505615

A Phase I-II Study of Novel Oncolytic Virus VG161 Via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ding-Wei Ye · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase I-II Study of Novel Oncolytic Virus VG161 via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (VG-INFUSE Trial) Background: The treatment of recurrent/refractory non-muscle-invasive bladder cancer (NMIBC), particularly BCG-unresponsive disease, remains a significant clinical challenge. Oncolytic virotherapy represents a promising novel therapeutic strategy. This study aims to evaluate the safety, preliminary efficacy, and biological activity of VG161, a novel oncolytic virus, administered via intravesical instillation. Methods: This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center, led by Drs. Zhang Hailiang and Ye Dingwei. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA). Expected Outcomes: This trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer.

Conditions

• NMIBC

Interventions

Type	Name	Description
DRUG	VG161 via Intravesical Instillation	This trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer.

Timeline

• Start date: 2021-10-12
• Primary completion: 2023-04-28
• Completion: 2023-05-30
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: China