FS120 Phase 1/1b Study in Patients With Advanced Malignancies

Exclusion Criteria

• •Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.
• •Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).
• •Prior radiotherapy within 2 weeks of start of study treatment.
• •HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
• •Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.
• •Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.
• •Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement.
• •Vaccination with a live vaccine within 30 days before first dose of study drug.
• •Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.
• •Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.