NCT04859751

Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer

An Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Intravesical VB4-845 Injection in Patients With Non-Muscle Invasive Bladder Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. VB4-845 injection is an experimental agent that may provide an alternative to cystectomy

Detailed description

Bladder cancer is the 6th most common cancer in the United States, affecting more men than women. The usual first treatment for NMIBC (Ta, T1,and CIS) is transurethral resection of the bladder tumors followed by intravesical immunotherapy, most commonly with bacillus Calmette-Guérin (BCG). Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS and high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. For patients unable or unwilling to undergo cystectomy, treatment options are limited. VB4-845 injection is a recombinant fusion protein produced in Escherichia coli (E. coli) that expresses a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to exotoxin A (ETA\[252-608\]). Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis. This is an open-label, non-randomized, multicenter bridging study in Chinese patients with NMIBC, specifically CIS (with or without papillary disease), high-grade Ta or any grade T1 papillary disease, who have previously failed BCG treatment (i.e., not those who are intolerant) with or without interferon. The study consists of a Screening period, a 12-week Induction Phase, and a Maintenance Phase of up to 21 monthly cycles for a total treatment period of up to104 weeks.

Conditions

• Non-Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	VB4-845 Injection	Intravesical administration of VB4-845 Injection.

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-06-01
• Completion: 2023-12-01
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: China