NCT05879627

To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors

A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of BAT8007 for injection in patients with advanced solid tumors.

Detailed description

This is a multicenter, open, dose increasing and dose expanding Phase I clinical study. About 169\~292 patients will be enrolled from research centers in China, the United States, Australia, etc. In the dose increasing stage, accelerated titration and "3+3" dose increasing design were used to explore the safety, tolerance and PK characteristics of BAT8007 for injection in patients with advanced solid tumors. During the dose increasing test, select the appropriate dose according to the previous study data for the extended study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BAT8007 for injection	Intravenous infusion: once every three weeks.The infusion time in the first cycle is recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can be completed within 30\~120 minutes.

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-08-18
• Completion: 2026-03-31
• First posted: 2023-05-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: China