Status:
RECRUITING
A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Byondis B.V.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06932952
Start Date
May 7 2025
End Date
September 1 2027
Last Update
August 20 2025
Active Locations (6)
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1
Institut Jules Bordet
Brussels, Belgium
2
UZ Leuven
Leuven, Belgium
3
CIOCC Hospital Universitario HM Sanchinarro
Madrid, Spain
4
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain