Study of Xilonix™
Research type
Research Study
Full title
A Phase III Double-blinded, Placebo Controlled Study of Xilonix™ in Metastatic Colorectal Cancer
IRAS ID
186331
Contact name
David Cunningham
Contact email
Sponsor organisation
XBiotech Germany GmbH
Eudract number
2012-005287-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 29 days
Research summary
This is a phase III, multicentre, double blind, randomized, placebo controlled pivotal trial of the True Human monoclonal antibody MABp1 (Xilonix™) in subjects with metastatic colorectal cancer who are refractory to standard therapy. Subjects will be randomized on a 2:1 basis to either take Xilonix™ with Best Supportive care or placebo with Best supportive care.
Xilonix™ is expected to inhibit tumour growth and metastasis by interrupting crucial signals that drive angiogenesis and invasiveness. The antibody therapy may also block tumour microenvironment infiltration by leukocytes (such as myeloid suppressor cells) that suppress antitumor immunity, enabling better host immune control of the disease. In addition to local effects on the tumour, Xilonix™ is expected to work systemically to correct the metabolic dysregulation, fatigue and anxiety mediated by chronic inflammatory signalling to the central nervous system.
The total study duration is 18 months. The duration of subject participation in the evaluation of body composition is approximately 77 days (including a screening period of 14 days and a treatment/follow up period of 63 days). Subjects with radiographic evidence of progression, as assessed by the Immune Related Response Criteria (irRC) should be discontinued from therapy.
REC name
West of Scotland REC 1
REC reference
15/WS/0248
Date of REC Opinion
13 Jan 2016
REC opinion
Further Information Favourable Opinion