A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract
This study aims to determine the safety and tolerability of TMV-018 when given alone or in combination with the prodrug 5-Fluorocytosine (5-FC) or an anti-PD-1 checkpoint inhibitor in patients with gastrointestinal tumors. Furthermore, the maximum tolerated dose (MTD) and recommended Phase II dose of TMV-018 shall be determined.
Full title of the trial: A Phase I/II open-label, dose-escalation, safety, clinical activity, pharmacokinetic and pharmacodynamic study of intra-tumoral application of TMV-018 in combination with 5-Fluorocytosine or anti-PD-1 therapy in patients with tumors. - TMV-018-101