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 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.

NCT Number	NCT07228442
Lead Sponsor	Philogen S.p.A.
Conditions	Locally Advanced Cutaneous Squamous Cell Carcinoma
Enrollment	92 participants
Start Date	2026-09
Primary Completion	2031-02 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-24