L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)

NCT07227350 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: PH-L19IL2TNFCOMB-04/242025-523229-16-00
• Study Type: interventional
• Target: 180
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

Locally Advanced Basal Cell Carcinoma

Keywords

Basal Cell Carcinoma; locally advanced; subcutaneous lesions; cutaneous lesions

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate

  Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.

  from enrollment to week 16

Study Arms (3)

L19IL2

EXPERIMENTAL

Patient will receive intralesional injections of monotherapy 13 Mio IU (\~2.17 mg) L19IL2. Frequency and duration are identical for all arms.

Drug: L19IL2

L19IL2/L19TNF

EXPERIMENTAL

Patient will receive intralesional injections of Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF. Frequency and duration are identical for all arms.

Drug: L19IL2/L19TNF

L19TNF

EXPERIMENTAL

Patient will receive intralesional injections of monotherapy 0.4 mg L19TNF. Frequency and duration are identical for all arms.

Drug: L19TNF

Interventions

L19IL2 DRUG

Intratumoral injections

L19IL2

L19TNF DRUG

Intratumoral injections

L19TNF

L19IL2/L19TNF DRUG

Intratumoral injections

L19IL2/L19TNF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.
• Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.
• Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment.
• Patients may have received prior surgery and/or radiation therapy.
• Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
• Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, plastic surgeon or surgical/medical oncologist. Acceptable medical contraindications to surgery include:
• BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely;
• Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);
• Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);
• Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.
• Prior radiotherapy to the target lesions must be completed at least 4 weeks prior to first study drug administration, with all acute RT-related toxicities resolved to ≤ Grade 1.
• Male or female patients, who are capable of giving consent, age ≥ 18 years.
• ECOG Performance Status/WHO Performance Status ≤ 1.
• Hemoglobin \> 10.0 g/dL.
• Platelets \> 100 x 109/L.

You may not qualify if:

• Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin (surgically removed 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.
• Current topical or systemic chemotherapy, targeted therapy immunotherapy.
• Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
• Chronically impaired renal function as indicated by creatinine clearance \< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \< 45 mL/min/1.73m2.
• Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
• History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
• Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
• Known arterial aneurysms.
• INR \> 3.
• Uncontrolled hypertension.
• Known uncontrolled coagulopathy or bleeding disorder.
• Known hepatic cirrhosis or severe pre-existing hepatic impairment.
• Moderate to severe respiratory failure.
• Active autoimmune disease that has required systemic treatment in past 2 years.
• Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (18)

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

The Ohio State University Wexner Medical Center Clinical Laboratories

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Universitaetsklinikum Augsburg

Augsburg, 86179, Germany

RECRUITING

Charite Universitaetsmedizin Berlin KöR

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Essen AöR

Essen, 45147, Germany

RECRUITING

Universitaetsklinikum Halle (Saale) AöR

Halle, 06120, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein AöR

Kiel, 24105, Germany

RECRUITING

Universitaetsklinikum Tuebingen AöR

Tübingen, 72076, Germany

RECRUITING

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, 16121, Greece

NOT YET RECRUITING

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Humanitas Mirasole S.p.A.

Rozzano, 20089, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Senese

Siena, 53100, Italy

RECRUITING

Hospital Clinic De Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

daromun

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Central Study Contacts

Lisa Nadal

CONTACT

05771526723; lisa.nadal@philogen.com

Concetta Aulicino

CONTACT

+39057717816; regulatory@philogen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); ES (1); IT (4); DE (6); US (6)