drugset / Trial / NCT05378737

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

NCT05378737 ↗

Phase 1 Completed 216 enrolled Bio-Thera Solutions
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-07-06
Primary completion
2025-12-08
Completion
2025-12-08

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT8006 Monoclonal antibody 1.2 mg/kg Intravenous
Subject BAT8006 Monoclonal antibody 2.4 mg/kg Intravenous
Subject BAT8006 Monoclonal antibody 3 mg/kg Intravenous
Subject BAT8006 Monoclonal antibody 3.6 mg/kg Intravenous
Subject BAT8006 Monoclonal antibody 84 mg/m2 Intravenous
Subject BAT8006 Monoclonal antibody 93 mg/m2 Intravenous

Indications