drugset / Trial / NCT06640413

A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors

NCT06640413

Phase 1 Recruiting 56 enrolled Philogen S.p.A.
Non-randomizedSequentialOpen-labelTreatment

Summary

The aim of this study is to assess the safety of \[177Lu\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).

Timeline

Start
2025-10-31
Primary completion
2028-05-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Darleukin Protein / enzyme biologic 2.25e+07 iu
Subject [177Lu]Lu-OncoFAP-23 Other / unclassified 3700 mbq
Subject [177Lu]Lu-OncoFAP-23 Other / unclassified 7400 mbq
Subject [177Lu]Lu-OncoFAP-23 Other / unclassified 11100 mbq

Indications

No indication recorded.