RecruitingPhase 2NCT07228442

L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of Intratumoral Administration of L19IL2/L19TNF in Locally Advanced Cutaneous Squamous Cell Carcinoma Patients Progressing on or Intolerant to Systemic Treatment


Sponsor

Philogen S.p.A.

Enrollment

92 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called L19IL2/L19TNF for people with locally advanced cutaneous squamous cell carcinoma. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL19IL2/L19TNF

intratumoral administrations


Locations(19)

UC Irvine Health- Chao Family Comprehensive Cancer Center

Orange, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center Clinical Laboratories

Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Universitaetsklinikum Augsburg

Augsburg, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

Universitaetsklinikum Essen AöR

Essen, Germany

Universitaetsklinikum Halle (Saale) AöR

Halle, Germany

Universitaetsklinikum Heidelberg AöR

Heidelberg, Germany

Universitaetsklinikum Schleswig-Holstein AöR

Kiel, Germany

Universitaetsklinikum Tübingen AöR

Tübingen, Germany

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, Greece

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Humanitas Mirasole S.p.A.

Rozzano, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Hospital Clinic De Barcelona

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT07228442


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