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NCT07227350 · ClinicalTrials.gov registry record · Phase 2
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
A Phase 2 study, sponsored by Philogen S.p.A..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT07227350: Recruiting Phase 2 study, sponsored by Philogen S.p.A..
NCT07227350 is a Phase 2 study that is actively recruiting participants, run by Philogen S.p.A.. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227350, a Phase 2 study, is actively recruiting participants, sponsored by Philogen S.p.A..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Newly injectable lesions occurring within the 4-week treatment period of the initial target lesion will also receive multiple intratumoral administrations of immunocytokines once weekly for up to 4 weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment
Primary Outcome
Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.
Interventions
- DRUG L19TNF
- DRUG L19IL2
- DRUG L19IL2/L19TNF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2031-02 |
| Phase | Phase 2 |
What NCT07227350 shows while recruiting
NCT07227350 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which L19TNF is the first listed.
NCT07227350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07227350 about?
NCT07227350 is a clinical study titled "L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)". Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objective...
What is the current status of trial NCT07227350?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2026-06-01. Estimated completion is 2031-02.
What interventions are being tested in trial NCT07227350?
The interventions under investigation include: L19TNF (DRUG), L19IL2 (DRUG), L19IL2/L19TNF (DRUG).
Who is sponsoring clinical trial NCT07227350?
This trial is sponsored by Philogen S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07227350's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 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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