NCT06046742

A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients with Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Detailed description

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	M1-c6v1	Intravenous drip administration

Timeline

• Start date: 2024-07-10
• Primary completion: 2026-06-30
• Completion: 2026-12-20
• First posted: 2023-09-21
• Last updated: 2025-03-13

Locations

3 sites across 1 country: Japan