NCT05414136

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006

A Single-arm, Open, Dose-increasing Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 in Patients with Her2-positive Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of BAT1006 after single and multiple dosing; 2) To study the immunogenicity of BAT1006; 3) Preliminary evaluation of anti-tumor efficacy of BAT1006.

Detailed description

This trial is an open phase I, dose-escalation clinical study. The first administration period was the 21st day, namely the DLT observation period. DLT observation was conducted to explore the safety, tolerability, pharmacokinetics and immunogenicity of MTD, single administration. After the observation period of DLT, the drug was administered once every 3 weeks, and the tolerance, pharmacokinetics, immunogenicity and preliminary effectiveness of multiple administration were evaluated. If some dose groups show better efficacy, the investigator and the sponsor may select 1-2 dose groups that have been found to have efficacy after negotiation and discussion for extended study to further explore the safety and efficacy of the drug.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BAT1006	Intravenous fluids

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2022-06-10
• Last updated: 2024-12-24

Locations

2 sites across 1 country: China