MedTrace Logo

Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

NCT04819399 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-05

No results posted yet for this study

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).

Conditions

  • Urinary Bladder Neoplasms

Interventions

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

Sponsors & Collaborators

  • Lindis Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • R Oberneder, MD · Urologische Klinik München-Planegg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2022-12-30
Completion
2023-12-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819399 on ClinicalTrials.gov