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Brief Title: A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
Official Title: 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
Study ID: NCT06046742
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
St. Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan
Name: Guangzhou Virotech Pharmaceutical Co., Ltd.
Affiliation: Guangzhou Virotech Pharmaceutical Co., Ltd.
Role: STUDY_CHAIR