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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 is a Phase 2 study that is actively recruiting participants, run by Philogen S.p.A.. The registered enrollment target is 180 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07227350
The ClinicalTrials.gov registry entry for NCT07227350 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philogen S.p.A., which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which L19TNF is the first listed.
NCT07227350 reports 0 study locations.
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.
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