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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 17, 2020

Primary Completion Date

February 23, 2023

Study Completion Date

February 23, 2023

Conditions
Colorectal Neoplasms
Interventions
BIOLOGICAL

TG6002

"Phase I part: Dose escalation from 1 x 10E6 PFU to 1 x 10E9 PFU. Phase II part: Established recommended Phase II dose (RP2D).~Intrahepatic arterial (IHA) administration on Day 1 within a 14-day cycle of TG6002/5-FC combination treatment.~A second cycle of TG6002/5-FC combination starting with TG6002 (IHA) administration at the same dose on Day43 can be initiated if no progressive disease or Dose Limiting Toxicity event in between; maximum 2 cycles of TG6002/5-FC combination treatment for each patient."

DRUG

Flucytosine (5-FC)

"Oral administration 4 times per day at the total dose of 200 mg/kg/day for 10 consecutive days per 14-day cycle of TG6002/5-FC combination.~A second cycle of TG6002/5-FC combination will be initiated if no progressive disease or Dose Limiting Toxicity event in between."

Trial Locations (3)

69008

Centre Léon Bérard, Lyon

94800

Institut Gustave Roussy, Villejuif

LS9 7TF

NHS St James's University Hospital, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Transgene

INDUSTRY