NCT07093814

A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent/progressive glioblastoma.

Detailed description

This study is an open-label, single-arm Phase I/II clinical trial comprising two parts: Phase I and Phase II. Phase I is a dose-escalation phase, with the primary objective of assessing the safety and tolerability of VRT106 at escalating doses in subjects with recurrent/progressive glioblastoma and confirming the Recommended Phase II Dose (RP2D). Phase II is a dose-expansion phase, in which subjects will receive VRT106 at the RP2D dose level, aiming to further evaluate the efficacy and safety of VRT106 in subjects with recurrent/progressive glioblastoma.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	VRT106	VRT106,intravenous

Timeline

• Start date: 2025-09-02
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2025-07-30
• Last updated: 2026-01-02

Locations

11 sites across 1 country: China