Clinical Trial

Safety and Early Signs of Efficacy of IL12-L19L19.

Study acronym: DODEKA
Recruiting Phase 1
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-07-13; most recent amendment 2026-01-12.
Trial Details
NCT Number NCT04471987
Lead Sponsor Philogen S.p.A.
Conditions Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 80 participants
Start Date 2020-07-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-14