drugset / Trial / NCT05405621

Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009

NCT05405621 ↗

Phase 1 Unknown 48 enrolled Bio-Thera Solutions
Non-randomizedSequentialOpen-labelTreatment

Summary

Primary objectives: * To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours. * To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).

Timeline

Start
2022-08-02
Primary completion
2023-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT8009 Unknown 0.6 mg/kg Intravenous
Subject BAT8009 Unknown 1.2 mg/kg Intravenous
Subject BAT8009 Unknown 2.4 mg/kg Intravenous
Subject BAT8009 Unknown 3.6 mg/kg Intravenous
Subject BAT8009 Unknown 4.8 mg/kg Intravenous
Subject BAT8009 Unknown 6 mg/kg Intravenous
Subject BAT8009 Unknown 7.2 mg/kg Intravenous
Subject BAT8009 Unknown 8.4 mg/kg Intravenous

Indications

No indication recorded.