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

• 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.