Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Prior therapy with anti-CD40 therapy.
* Receipt of systemic anticancer therapy or radiotherapy within certain period of time.
* Prior exposure to immune-therapeutics experienced Grade ≥ 3 drug-related toxicity, or a toxicity requiring discontinuation.
* Received a live-virus vaccine within 30 days of the first dose of study drug.
* Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
* History of Grade ≥ 3 immune-related AEs (irAEs).
* Prolonged QT syndrome, or clinically significant cardiac condition.
* Receiving an immunologically based treatment for any reason.
* History or current active or chronic autoimmune disease.
* Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites drainage.
* Female patients who are pregnant or breastfeeding.
* History of hemorrhagic or ischemic stroke within the last 6 months.
* Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant or solid organ transplant.