A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients

HER2-Positive Solid Tumors Clinical Trial

Official title:
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

Status Active, not recruiting

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

HER2-Positive Solid Tumors

Clinical Trial Details

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

View Details

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