NCT03990233

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

An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: OSE Immunotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	BI 765063	mAb antagonist to SIRPα receptor, a myeloid checkpoint inhibitor
DRUG	BI 754091	mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor

Timeline

• Start date: 2019-04-16
• Primary completion: 2023-04-17
• Completion: 2025-04-30
• First posted: 2019-06-18
• Last updated: 2025-06-26

Locations

8 sites across 2 countries: Belgium, France