BioClin - B-701-U21 - B-701 vs Placebo in Urothelial Cell Carcinoma
Research type
Research Study
Full title
A Phase 1b/2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of B-701 Plus Docetaxel Versus Placebo Plus Docetaxel in the Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma in Subjects who have Relapsed After, or are Refractory to Standard Therapy
IRAS ID
234836
Contact name
Parikh Omi
Contact email
Sponsor organisation
BioClin Therapeutics EU B.V.
Eudract number
2017-001319-36
Clinicaltrials.gov Identifier
123185, IND Number
Duration of Study in the UK
4 years, 6 months, 8 days
Research summary
This is a clinical trial to investigate the safety and effect of a drug called B-701 given with another drug Docetaxel on certain types of bladder cancer that do not respond to treatment with standard therapy. \n\nB-701 is an intravenous drug, meaning that it is administered through a needle placed in a vein. B-701 is an antibody. Antibodies are proteins which stick to other proteins. B-701 sticks to a protein called “FGFR3” ( or “fibroblast growth factor receptor 3”), which has been found to be present or changed in genes in many types of human cancer, including bladder cancer. FGFR3 gene mutations are thought to be involved in cancer development, B 701 may help the cancer by blocking FGFR3 from working.\n\nIn this study participants will be treated B-701 along side docetaxel or treated with only B-701.\n\nThis study has 2 parts. Only once part 1 is complete can part 2 begin: \n\nIn part 1, participants will receive B-701 with docetaxel or on it’s own. \n\nIn part 2, participants will receive B-701 with docetaxel (66% chance) or placebo with docetaxel (33% chance).\nThis part will also be randomised, meaning participants or doctors will not know what a given participant is receiving.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0248
Date of REC Opinion
29 Nov 2017
REC opinion
Further Information Favourable Opinion