drugset
drugset / Trial / NCT05414136

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006

NCT05414136 ↗

Phase 1 Completed 37 enrolled Bio-Thera Solutions
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-02-10
Primary completion
2024-06-17
Completion
2024-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT1006 Monoclonal antibody 3 mg/kg Intravenous
Subject BAT1006 Monoclonal antibody 6 mg/kg Intravenous
Subject BAT1006 Monoclonal antibody 10 mg/kg Intravenous
Subject BAT1006 Monoclonal antibody 15 mg/kg Intravenous
Subject BAT1006 Monoclonal antibody 20 mg/kg Intravenous

Indications

neoplasm