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Clinical Trial Summary

An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors (breast cancer or gastric cancer)。


Clinical Trial Description

This is an open-label, dose escalation Phase I clinical study in two stages. Stage 1 consists of the first four cycles where the tolerability, safety, pharmacokinetics and immunogenicity of BAT8001 for injections will be studied and preliminary efficacy will be evaluated. Efficacy and safety assessments continue from the fifth cycle until disease progression or intolerable toxicities. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04189211
Study type Interventional
Source Bio-Thera Solutions
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 7, 2017
Completion date December 31, 2020

See also
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Active, not recruiting NCT04660929 - CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors Phase 1
Completed NCT04521179 - Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors Phase 2
Not yet recruiting NCT04501770 - A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors Phase 1