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Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine

NCT04799847 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2023-02-13

No results posted yet for this study

Summary

A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to Bacillus Calmette-Guerin (BCG) Vaccine

Conditions

Interventions

DRUG

Catumaxomab

This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 2 dose levels(20ug group and 100ug group）, in NMIBC patients are investigated.

Sponsors & Collaborators

  • LintonPharm Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04799847 on ClinicalTrials.gov