Trial Identifiers
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Scientific Title
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
Commercial Sponsor
Imugene Limited
Summary
This is a dose escalation and expansion trial. Dose escalation will occur across three monotherapy cohorts (10 μg/dose, 50 μg/dose and 100μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection)and one combination cohort, in which patients will receive standard of care treatment for non-small cell lung cancer in combination with MU-201 at a starting dose below the monotherapy optimal biological dose. Dose expansion will commence once an optimal biological dose of MU-201 is determined in the combination cohort of the dose escalation phase. Patients enrolled in the expansion cohort will receive IMU-201 in combination with standard of care treatment for non-small cell lung cancer.