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drugset / Trial / NCT05109650

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients

NCT05109650 ↗

Phase 1 Terminated 13 enrolled Bio-Thera Solutions
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.

Timeline

Start
2022-02-28
Primary completion
2023-03-23
Completion
2024-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT1308 Monoclonal antibody 300 mg Intravenous
Subject BAT6026 Monoclonal antibody 0.1 mg/kg Intravenous
Subject BAT6026 Monoclonal antibody 0.3 mg/kg Intravenous
Subject BAT6026 Monoclonal antibody 1 mg/kg Intravenous
Subject BAT6026 Monoclonal antibody 3 mg/kg Intravenous
Subject BAT6026 Monoclonal antibody 6 mg/kg Intravenous
Subject BAT6026 Monoclonal antibody 10 mg/kg Intravenous

Indications

No indication recorded.