CompletedPhase 1/2

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

China20 participantsStarted 2021-10-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Willing and able to provide written informed consent and to comply with the protocol.
✓. Age ≥ 18 years.
✓. Histologically or cytologically confirmed urothelial carcinoma of the bladder.
✓. Cystoscopically and pathologically (via biopsy) confirmed recurrence of non-muscle-invasive bladder cancer, with ≥ 3 prior recurrences.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Life expectancy ≥ 3 months.
✓. Adequate hematologic and end-organ function within 4 weeks prior to the first study treatment, defined as follows:
✓. For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to study entry, agreement to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the last dose, and must be non-lactating. For men: agreement to use effective contraception during the study and for 6 months after the last dose.

Exclusion criteria

What they're measuring

Relapse-Free Survival

Timeframe: 12 months from last participant enrolled

Incidence of treatment-related adverse events (TRAEs)

Timeframe: 12 months from last participant enrolled

Trial details

NCT IDNCT07505615

SponsorDing-Wei Ye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-28

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