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BioClin begins Phase II trial of B-701 to treat urothelial cell carcinoma

US-based BioClin Therapeutics has started a Phase II clinical study of B-701, an anti-FGFR3 antibody, being investigated to treat locally advanced or metastatic urothelial cell carcinoma, also called bladder cancer.

B-701 is a new human monoclonal antibody specific for fibroblast growth factor receptor 3 (FGFR3) that is being developed to target FGFR3-positive tumors.

The randomized, double-blinded, placebo-controlled, multicenter, parallel-group, efficacy and safety Phase II trial is evaluating B-701 in combination with docetaxel versus docetaxel alone for the treatment of patients with Stage IV, locally advanced or metastatic urothelial cell carcinoma.

The trial is being carried out in patients who have relapsed after, or are refractory to, one or two prior lines of chemotherapy which have not included a taxane.

Washington University School of Medicine Division of Oncology professor of Medicine and clinical investigator of the trial Joel Picus said: "Urothelial cell carcinoma in patients who failed first-line treatment is a devastating disease for which there is no approved or effective treatment."

The Phase II trial is divided into two phases: an open-label lead-in phase, which will evaluate the safety and potential early signal of efficacy of B-701 plus docetaxel, and the randomized phase, which will compare B-701 in combination with docetaxel vs. docetaxel alone.

The company also plans to begin an investigator-sponsored study later this year which will evaluate B-701 in combination with a clinical-stage immune checkpoint inhibitor in patients with advanced/metastatic urothelial cell carcinoma.