NCT05378737

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection

A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BAT8006 for Injection in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objectives: To evaluate the safety and tolerability of BAT8006 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.

Detailed description

In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8006 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BAT8006 for Injection	Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30\~120 minutes.

Timeline

• Start date: 2022-07-06
• Primary completion: 2025-12-08
• Completion: 2025-12-08
• First posted: 2022-05-18
• Last updated: 2026-01-06

Locations

17 sites across 1 country: China