NCT04819399

Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

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)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lindis Biotech GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	Catumaxomab	Procedure: 6 weekly intravesical administration at each dose level; 3 sequential cohorts consisting of 3 patients (part I) 1. cohort 50 µg 2. cohort 70 µg 3. cohort 100 µg Part II will be treated at recommended dose

Timeline

• Start date: 2020-07-07
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2021-03-29
• Last updated: 2022-04-05

Locations

1 site across 1 country: Germany