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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-14

No results posted yet for this study

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).

Conditions

Interventions

DRUG

[177Lu]Lu-OncoFAP-23

3.7, 7.4, or 11.1 GBq to define the RD

DRUG

L19IL2

22.5 Mio IU

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640413 on ClinicalTrials.gov