Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer

Summary

This study will include two parts: * Phase I part is a dose-escalation study to assess the safety of increasing doses of TG6002 in combination with oral flucytosine (5-FC) in consecutive cohorts of 3 to 6 patients with colorectal cancer and unresectable liver metastases according to a 3+3 design * Phase IIa part is an extension of the phase I part at the recommended phase II dose to evaluate the efficacy of TG6002 in combination with oral flucytosine (5-FC) in patients with colorectal cancer and unresectable liver metastases. In both parts, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed until disease progression, death due to any cause or the date of data cut-off, whichever occurs first.

Timeline

Start

2020-01-17

Primary completion

2023-02-23

Completion

2023-02-23

Drugs

Indications