Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC

Non-muscle Invasive Bladder Cancer (NMIBC) Clinical Trial

Official title:
A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin

Status Terminated

Clinical Trial Summary

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

Clinical Trial Description

BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression of a potent toxin specifically in malignant cells but not in normal tissue. It has been designed to exploit the established biology of the H19 gene, which is upregulated and expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells. ;

Study Design

Related Conditions & MeSH terms

Non-muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Neoplasms

Clinical Trial Details

NCT number	NCT03719300
Study type	Interventional
Source	Anchiano Therapeutics Israel Ltd.
Contact
Status	Terminated
Phase	Phase 2
Start date	March 20, 2019
Completion date	December 18, 2019

View Details

See also
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