NCT06932952

A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors

A Dose Escalation and Expansion Trial With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Byondis B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab.

Detailed description

This study includes a dose escalation part (Part 1) in which the MTD or OBD and RDE(s) will be determined. This trial includes an expansion part (Part 2) to evaluate efficacy and safety of BYON4228 in combination with pembrolizumab in specific patient cohorts. BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BYON4228 + Pembrolizumab	BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every three weeks until disease progression or unacceptable toxicity. Different doses. Pembrolizumab IV infusion (200 mg) every three weeks from the second treatment cycle onwards.

Timeline

• Start date: 2025-05-07
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2025-04-17
• Last updated: 2026-01-16

Locations

6 sites across 3 countries: Belgium, Spain, United Kingdom