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

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.