L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma

Conditions

• Locally Advanced Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• L19IL2/L19TNF — DRUG
  intratumoral administrations

Study Details

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.

Key Dates

First listed

Nov 14, 2025

Start date

Sep 30, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2031

Completion

Feb 28, 2031

Study Design

Enrollment

92 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  the patients will receive multiple intratumoral administrations of a mixture of L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks.

Primary Outcome Measure

Overall Response Rate (BORR) [ Time Frame: From enrollment up to a maximum of 160 weeks after the start of treatment ]

Central Contacts

• Lisa Nadal
  +3905771526723
  [email protected]
• Concetta Aulicino
  +39057717816
  [email protected]

Locations (6)

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