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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities — 21 days
Objective Response Rate — 2 years Part 2 (expansion): To evaluate the objective tumor response rate (ORR).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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