NCT05095441

A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma

A Phase 1 Open-Label Study of Genetically Engineered Oncolytic HSV-1 (C5252) Expressing IL-12 and Anti-PD-1 Antibody in Patients With Recurrent or Progressive Glioblastoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: ImmVira Pharma Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).

Detailed description

This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single IT injection of C5252 in patients with recurrent or progressive GBM. The Part 1 portion of the study is a 3+3 design to evaluate escalating doses of C5252. Total enrollment will depend on the toxicities and/or activity observed, with approximately 36 evaluable participants enrolled. Once the recommended dose (RD) is identified from Part 1, Part 2 Dose Expansion will enroll up to 15 additional participants to further assess the safety, tolerability, and preliminary efficacy of a single IT injection of C5252 monotherapy.

Conditions

• Solid Tumor
• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma Multiforme of Brain

Interventions

Type	Name	Description
BIOLOGICAL	C5252	A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-04-30
• Completion: 2026-04-30
• First posted: 2021-10-27
• Last updated: 2022-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study