L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)
Philogen S.p.A.
180 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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. Patients will be followed for a maximum of 156 weeks after beginning of treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Intratumoral injections
Intratumoral injections
Intratumoral injections
Locations(18)
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NCT07227350