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

Open to people ages 18 years and up

• Males or females aged ≥ 18 years.
• Ability to understand and willingness to sign a written informed consent document.
• Patients must have a histologically or cytologically confirmed metastatic or unresectable malignancy.
• Estimated life expectancy, in the judgment of the Investigator, of at least 90 days.
• Adequate bone marrow, liver, and renal functions.
• Men and women of childbearing potential must agree to take highly effective contraceptive methods.
• Patients should recover from all reversible AEs of previous anticancer therapies to baseline.
• Patients infected with the HIV virus will be eligible if the disease is under control of effective therapy.

• 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.