A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

Exclusion Criteria

• •Symptomatic central nervous system (CNS) metastases or primary CNS lymphoma
• •History of allogeneic bone marrow, stem-cell, or solid organ transplant
• •History of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
• •Treatment with any systemic chemotherapy within 3 weeks prior to the initiation of study drug; treatment with biologics or investigational therapy within the 4 weeks prior to the initiation of study drug.
• •Major surgery within 4 weeks prior to the initiation of study drug.
• •Prior treatment with combination of monoclonal antibodies against PD-1 and LAG-3 (Cohort Expansion only).
• •Treatment with radiation therapy within 2 weeks prior to the initiation of study drug.
• •Clinically significant cardiovascular disease.
• •QTcF prolongation \> 480 milliseconds
• •HER2+ cohort: left ventricular ejection fraction less than 50%
• •Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
• •Active pneumonitis or history of non-infectious pneumonitis.
• •Clinically significant gastrointestinal disorders.
• •Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• •Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
• •Known history of hepatitis B (except in hepatocellular carcinoma) or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
• •Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
• •Dementia or altered mental status that would preclude understanding and rendering of informed consent
• •Confirmed or presumed COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards. Patients with a positive test result for SARS-CoV-2 infection, known asymptomatic infection, or presumed infection are excluded. Patients may be considered eligible after a resolved SARS-CoV-2 infection once he or she remains afebrile for at least 72 hours and after other SARS-CoV-2-related symptoms have fully recovered to baseline for a minimum of 72 hours.