NCT06126510

Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.

Detailed description

This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred. If the subject VG161 injection target lesion shrinks after treatment and can no longer receive intratumoral injection administration of this administered dose of VG161, after evaluation by the investigator, it is allowed to reduce the dosing dose or suspend the administration as appropriate according to the size of the injectable lesion. After the end of treatment, there will also be an end-of-treatment visit and a post-treatment safety visit. Subjects who end the study for reasons not attributable to disease progression will undergo imaging evaluation at the end of treatment (if no imaging evaluation is performed within 4 weeks) and have imaging every 3 months after the end of treatment until disease progression or death or initiation of new anti-tumor therapy (whichever occurs first) to assess the time to disease progression. After the end of treatment, the subjects will also receive survival follow-up once every 3 months, and the survival status of the subjects and subsequent anti-tumor therapy will be collected and recorded until death, loss to follow-up or 1 year after the last dose (whichever occurs first).

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)	VG161:1.0×10\^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-07-17
• Completion: 2026-01-17
• First posted: 2023-11-13
• Last updated: 2024-12-24

Locations

1 site across 1 country: China