A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms (CP-MGD013-01)
Johns Hopkins Kimmel Cancer Center in Baltimore
To investigate safety and tolerability of MGD-013 to determine maximum tolerated dose and recommended Phase 2 dose in patients. To determine the pharmacokinetic profile and immunogenicity of MGD-013.
Patients must be 18 years or older with confirmed unresectable, recurrent, locally-advanced or metastatic solid tumors with measurable disease and must have progressed following prior treatment and have no standard therapy options left. Good performance status as determined by study team evaluation. Adequate laboratory values as determined at screening. Side effects from prior immunotherapy treatment must have resolved. No pregnant or breast feeding females. All participants, male and female must agree to adequate birth control measures during and for a period after treatment completion. No CNS disease; if there is a history then patient must have been treated and have no symptoms. No history of a transplant. No autoimmune disease. No radiation therapy within 2 weeks prior to start. No systemic steroids. No significant gastrointestinal, pulmonary, or cardiovascular disorders. No active infection within 7 days. No known history of human immunodeficiency virus (HIV), active hepatitis B or hepatitis C. No history of trauma or major surgery within 4 weeks. No live vaccines within 4 weeks. No known psychiatric disorders that would interfere with cooperation with the requirements of the study.
MGD-013 is an immune checkpoint modulator. This drug will be administered by IV over 60 minutes every 2 weeks. Patients must come to clinic at set time points per study calendar.
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