TG6002.03 - version 1.0
Research type
Research Study
Full title
A dose-escalation and phase IIa study of TG6002 plus flucytosine in patients with unresectable colorectal cancer with liver metastases
IRAS ID
260945
Contact name
Adel Samson
Contact email
Sponsor organisation
TRANSGENE S.A.
Eudract number
2018-004103-39
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
TG6002.03 study in patients with advanced colorectal cancer with liver metastases (CRCLM):
Even though the clinical outcome for patients with CRCLM has improved over the past decade, there is still a high medical need for safe and efficient treatments in this indication. TG6002.03 will study the safety and efficacy of a combination of two investigational medicinal products, TG6002, administered by the intra-hepatic artery route, and flucytosine, administered by the oral route, in subjects with CRCLM. TG6002 derives from the virus which had been used to vaccinate against smallpox. TG6002 has been genetically modified to selectively multiply in cancer cells and convert flucytosine, a medication used against fungal infections in some European countries and in the USA, into cytotoxic agents including 5-FU, a medication used since the 1960’s to treat advanced cancers.
TG6002.03 is a two-part study. The phase I part is a dose escalation. It means that cohorts of 3 to 6 patients will successively be treated with a TG6002 dose that will be increased based on safety data obtained in the previous cohort. Flucytosine dose will be fixed at the marketed fungal drug dose. The phase I objective is to determine the best tolerated dose of TG6002 in combination with flucytosine. The phase IIa part consists of a group of patients receiving TG6002 at the dose determined in phase I and flucytosine. The anti-tumoural activity of TG6002/flucytosine will be assessed through tumour size measurement. The St James’ Hospital in Leeds will conduct this study which is sponsored by TRANSGENE. A maximum of 75 subjects will be included in TG6002.03. The participation duration for a patient will be of 43 days corresponding to one course of TG6002/flucytosine. An additional course will be possible if the subject disease is improving or stable and TG6002/flucytosine is well tolerated.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1260
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion