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Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

Urinary Bladder Neoplasms Clinical Trial

Official title:
Phase I, Open Label, Dose Escalating Study to Investigate Safety and Tolerability of Intravesical Application of Trifunctional Anti-EPCAM x Anti-CD3 Antibody Catumaxomab in Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Clinical Trial Summary

The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC).

Clinical Trial Description

The present Phase I dose escalation study (CATUNIBLA) in patients with non-muscle invasive bladder cancer (NMIBC) of high and intermediate risk for progression aims at investigating the therapeutic potential of Catumaxomab applied as intravesical instillation. Catumaxomab is an intact trifunctional bispecific monoclonal antibody and has the molecular targets EpCAM and CD3. It mediates antibody-dependent cellular cytotoxicity against human epithelial tumor cells including bladder cancer. The study consists of two parts: Part I is dose finding and will investigate 3 sequential cohorts consisting of 3 patients to be enrolled at the specified dose levels. After determination of the dose for Part II an additional number (n=X) of patients will be included at this dose level. Part I and part II have a screening period, 6 week treatment phase and a follow-up phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04819399
Study type Interventional
Source Lindis Biotech GmbH
Contact Horst Lindhofer, Dr
Phone 498970076624
Email horst.lindhofer@lindisbiotech.de
Status Recruiting
Phase Phase 1
Start date July 7, 2020
Completion date December 30, 2023
View Details
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