drugset / Trial / NCT04471987

Safety and Early Signs of Efficacy of IL12-L19L19.

NCT04471987 ↗

Phase 1 Recruiting 80 enrolled Philogen S.p.A.
NaSequentialOpen-labelTreatment

Summary

The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune checkpoint blockade therapy. The primary objective of the study is to evaluate the safety of IL12-L19L19 and to establish MTD in order to establish a recommended dose (RD). The secondary objectives of the study are to assess early signs of efficacy, the determination of pharmacokinetic (PK) properties and the immunogenicity of IL12-L19L19.

Timeline

Start
2020-07-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IL12-L19L19 Monoclonal antibody — —