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

NCT06932952 | Active Not Recruiting Phase 1

• 2 other identifiers: BYON4228.0022024-517952-37-00
• Study Type: interventional
• Target: 7
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Solid Tumor

Keywords

mAB; Monoclonal antibody; SIRPα; CD47; SIRP

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities

  21 days

• Objective Response Rate

  Part 2 (expansion): To evaluate the objective tumor response rate (ORR).

  2 years

Study Arms (1)

BYON4228 + Pembrolizumab

EXPERIMENTAL

Drug: BYON4228 + Pembrolizumab

Interventions

BYON4228 + Pembrolizumab DRUG

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.

BYON4228 + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:
• Part 1 (dose escalation): Solid tumors of any origin;
• Part 2 (expansion): Patients with other solid tumor types indicated for pembrolizumab monotherapy;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
• For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1);
• Adequate baseline organ function.

You may not qualify if:

• Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment;
• History of hypersensitivity or allergic reaction to any of the excipients of BYON4228;
• Any contraindication to pembrolizumab treatment;
• For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation;
• Symptomatic brain metastases;
• History of autoimmune disorders;
• Severe active infection or other severe uncontrolled systemic disease;
• Having clinically significant cardiovascular disease;
• Known infection of Hepatitis B, C or E.

Sponsors & Collaborators

• Byondis B.V.: lead

Study Sites (6)

Institut Jules Bordet

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CIOCC Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

The Royal Marsden

Sutton, United Kingdom

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: May 7, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ES (2); GB (2); BE (2)