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
← catalyst calendarNCT06640413 · readout in 650 d
Sponsored by Philogen S.p.A. (industry) · PHIL.MI — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
56estimated
Sites
4
Country
Italy
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-31 | actual | When the study began enrolling |
| Primary completion | 2028-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- FAP
Interventions
- Drug: [177Lu]Lu-OncoFAP-23
- Drug: L19IL2
Primary outcomes
what the primary-completion date above is the date OFDose Limiting Toxicity
measured From Day 1 to 28 of the dose escalation part
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
measured From Day 1 to 28 of the dose escalation part
Maximum Administered Dose (MAD)
measured From Day 1 to 28 of the dose escalation part
Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured through study completion, maximum 1 year
Drug Induced Liver Injury (DILI)
measured through study completion, maximum 1 year
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