The "INSIGHT" trial: An explorative, open-labeled phase I study to evaluate the feasibility and safety of intra-tumoral, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumor entities.

TPS3129Background: The INSIGHT study evaluates feasibility and safety of intratumoral and intraperitoneal injections of IMP321 (mono-agent) for the treatment of advanced stage solid tumors as well as to generate first efficacy data. This proof-of-concept data could build the basis for further clinical studies exploring the therapeutic potential of active immunotherapy with IMP321 by direct injection into the tumor mass or the peritoneal space. Furthermore, safety and efficacy of combining standard-of-care (SOC) chemo(immuno-)therapies with IMP321 subcutaneous (s.c.) injections in various solid tumor entities will be assessed. IMP321 is a soluble form of the LAG-3 T cell surface receptor with a dual mode of action (MOA) consisting of activation of antigen presenting cells (primary MOA) and prevention of exhaustion of activated T-cells (secondary MOA at high local concentration). Methods: This is a prospective investigator initiated phase I trial consisting of three strata. Stratum A: Pretreated patients wi...