FS120 First in Human Study in Patients With Advanced Malignancies

This is an interventional treatment trial for Advanced Cancer focused on measuring Immuno-oncology, Bispecific antibody, Dose escalation, Cohort expansion, OX40, CD137 (4-1BB), F-star, Pembrolizumab, PD-1 Read More

Inclusion Criteria:

• Age ≥18 years.
• Measurable disease.
• Eastern Cooperative Oncology Group Performance Status 0-1.
• The participant agrees to undergo a pretreatment and on-treatment biopsy of the tumor.
• Highly effective contraception.
• A female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception.
• Participants with human immunodeficiency virus (HIV) who are healthy and have a low risk of acquired immunodeficiency syndrome related outcomes.
• For monotherapy part: participants must have histologically confirmed, locally advanced, unresectable or metastatic solid tumors of specific types.
• For combination part: participants must have histologically confirmed, locally advanced, unresectable or metastatic solid tumors where there is regulatory approval for use of pembrolizumab as a monotherapy agent.

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 therapy with more than 1 line of treatment with immune-checkpoint inhibitors (including ICB combination therapy).
• 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; systemic inflammatory response syndrome.
• Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade >1 NCI CTCAE Version 5.0 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 judgment.
• 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.