Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy

Exclusion Criteria

• •Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment.
• •Previous radiotherapy within 14 days of the first dose of study treatment.
• •Known active CNS metastasis and/or carcinomatous meningitis.
• •Has received a live-virus vaccine within 30 days.
• •Has had a Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
• •Abnormality of QT interval or syndrome.
• •Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE.
• •Patients who are receiving an immunologically-based treatment for any reason.
• •Treatment with systemic immune-stimulatory agents within 4 weeks prior to the first dose of study drug.
• •Active or chronic autoimmune disease that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
• •Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months.
• •Has an active infection requiring intravenous (i.v.) anti-infectives within 14 days before the first dose of study treatment.
• •Current evidence or history of interstitial lung disease or active, noninfectious pneumonitis requiring treatment such as oral or intravenous glucocorticoids to assist with management.
• •Female patients who are pregnant or breastfeeding.
• •Any evidence of severe or uncontrolled systemic disease.
• •Any other disease or clinically significant abnormality in laboratory parameters.
• •Has previously had a stem cell or bone marrow or solid organ transplant.