NCT04189211

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)。

Detailed 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.

Conditions

• HER2-Positive Solid Tumors

Interventions

Type	Name	Description
DRUG	BAT8001	IV infusions.

Timeline

• Start date: 2017-03-07
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2019-12-06
• Last updated: 2019-12-06

Locations

1 site across 1 country: China