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Spots Global Cancer Trial Database for Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

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Trial Identification

Brief Title: Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

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)

Study ID: NCT04819399

Interventions

Catumaxomab

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Urologie Planegg, München, , Germany

Contact Details

Name: R Oberneder, MD

Affiliation: Urologische Klinik München-Planegg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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