drugset / Trial / NCT03990233

A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours

NCT03990233

RandomizedSequentialOpen-labelTreatment

Summary

This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal regulatory protein alpha (SIRPα) receptor, a myeloid checkpoint inhibitor administered as single agent, and in combination with BI 754091, a mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor.

Timeline

Start
2019-04-16
Primary completion
2023-04-17
Completion
2025-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 765063 Monoclonal antibody
Subject Ezabenlimab Monoclonal antibody

Indications