NCT03884517

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Cancer

Interventions

Type	Name	Description
DRUG	BAT8003	Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result

Timeline

• Start date: 2019-03-15
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2019-03-21
• Last updated: 2023-05-01

Locations

1 site across 1 country: China