drugset
drugset / Trial / NCT05073484

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients

NCT05073484 ↗

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

Summary

This first-in-human open-label, multi center, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of BAT6021 alone or in combination with BAT1308 (an anti-PD-1 antibody) in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Timeline

Start
2021-10-29
Primary completion
2023-03-30
Completion
2023-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT1308 Monoclonal antibody 300 mg Intravenous
Subject BAT6021 Monoclonal antibody 10 mg Intravenous
Subject BAT6021 Monoclonal antibody 30 mg Intravenous
Subject BAT6021 Monoclonal antibody 100 mg Intravenous
Subject BAT6021 Monoclonal antibody 300 mg Intravenous
Subject BAT6021 Monoclonal antibody 600 mg Intravenous
Subject BAT6021 Monoclonal antibody 900 mg Intravenous

Indications

No indication recorded.