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

A Phase I 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a prospective phase I, open-label, multiple ascending, multi-center dose escalation study to evaluate the safety and preliminary signs of efficacy of \[177Lu\]Lu-OncoFAP-23 alone and in combination with the antibody-cytokine conjugate L19-IL2 for the treatment of advanced/metastatic FAP-positive solid tumors. Eligible patients for this trial are male or non-pregnant and non-breastfeeding females aged 18 years or more, able to give informed consent. Up to 56 evaluable patients will be enrolled in the trial and the trial is divided into two parts: 1. Part I - Dose escalation part (2-36 pts) This dose escalation part of the study is designed as a standard 3+3 escalation scheme. Not more than 2 patients per cohort are treated simultaneously during the Dose Limiting Toxicity (DLT) observation period from Day 1 to Day 28 of the first cycle. Patients per cohort will be assigned to different dose levels of the study drug. 2. Part II - Dose expansion part (20 pts) After completion of the dose escalation part, additional 20 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications. Patients will be randomly assigned to arm 1 (monotherapy) or arm 2 (combination therapy) (10 patients each). Both in part I and II, patients can receive up to 4 consecutive cycles of radioligand therapy every 8 (± 1) weeks. The primary objective 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 FAP-positive malignancies and to establish a Recommended Dose (RD). Secondary objectives include evaluation of pharmacokinetics and the collection of initial signs of efficacy of the treatment.

Conditions

• FAP

Interventions

Type	Name	Description
DRUG	[177Lu]Lu-OncoFAP-23	3.7, 7.4, or 11.1 GBq to define the RD
DRUG	L19IL2	22.5 Mio IU

Timeline

• Start date: 2025-10-31
• Primary completion: 2028-05-31
• Completion: 2028-12-31
• First posted: 2024-10-15
• Last updated: 2026-01-14

Locations

4 sites across 1 country: Italy