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NCT07228442 · ClinicalTrials.gov registry record · Phase 2

L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma

A Phase 2 study, sponsored by Philogen S.p.A..

Not yet
Registry status
Phase 2
Development phase
92
Enrollment target

NCT07228442: Clinical Trial Phase 2 study, sponsored by Philogen S.p.A..

NCT07228442 is a Phase 2 study that has not yet begun recruiting, run by Philogen S.p.A.. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07228442, a Phase 2 study, has not yet begun recruiting, sponsored by Philogen S.p.A..

NOT YET RECRUITING
Registry status
Phase 2
Development phase
92 participants
Enrollment target

Study Summary

Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to Immune Checkpoint Inhibitor (ICI). The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2/L19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.

Primary Outcome

Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).

Interventions

  • DRUG L19IL2/L19TNF

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2026-02
Est. Completion 2031-02
Phase Phase 2
Philogen S.p.A.

7 total trials

What is known before NCT07228442 opens enrollment

NCT07228442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 1 intervention - of which L19IL2/L19TNF is the first listed.

NCT07228442 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07228442 about?

NCT07228442 is a clinical study titled "L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma". Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to Immune Checkpoint Inhibitor (ICI). The primary objective of the study is to...

What is the current status of trial NCT07228442?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2026-02. Estimated completion is 2031-02.

What interventions are being tested in trial NCT07228442?

The interventions under investigation include: L19IL2/L19TNF (DRUG).

Who is sponsoring clinical trial NCT07228442?

This trial is sponsored by Philogen S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07228442's enrollment target sits among peer trials

92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07228442, the US trial registry maintained by the National Library of Medicine. NCT07228442 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.