15
Participants
Start Date
January 17, 2020
Primary Completion Date
February 23, 2023
Study Completion Date
February 23, 2023
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."
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."
Centre Léon Bérard, Lyon
Institut Gustave Roussy, Villejuif
NHS St James's University Hospital, Leeds
Lead Sponsor
Transgene
INDUSTRY