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 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. Patients will be followed for a maximum of 156 weeks after beginning of treatment.

NCT Number	NCT07227350
Lead Sponsor	Philogen S.p.A.
Conditions	Locally Advanced Basal Cell Carcinoma
Enrollment	180 participants
Start Date	2026-06-01
Primary Completion	2031-02 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-31