Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer

Advanced Solid Cancer Clinical Trial

Official title: An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer

Status Terminated

Clinical Trial Summary

The trial is divided into three periods. Dosing will be the first day of each cycle, 21 days per cycle. The first period is the day of first study drug delivery until the 21st day, that is, the first treatment cycle. The DLT observation, exploration of MTD, safety of single administration, tolerance and pharmacokinetics, immunity Original research will happen during this period. The second period is a 2-8 dosing cycle, with multiple doses of tolerance, pharmacokinetics, immunogenicity studies, and preliminary efficacy evaluations. After a 2-4 cycle study, patients with good tolerance and no tumor progression will continue to the 5-8 cycle dosing study. The third period is to expand the study. After exploring the MTD, the investigator and the sponsor can discuss to extend another 10-30 cases in a safe and effective dose group to further study the effectiveness and safety of BAT8003 and its pharmacokinetics.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Solid Cancer

• NCT number: NCT03884517
• Study type: Interventional
• Source: Bio-Thera Solutions
• Status: Terminated
• Phase: Phase 1
• Start date: March 15, 2019
• Completion date: February 8, 2021