L19IL2/TNF for Locally Advanced Basal Cell Carcinoma
This study is testing a treatment called L19IL2/L19TNF for people with locally advanced basal cell carcinoma (a type of skin cancer). This is for patients whose cancer has not responded to or who cannot tolerate other treatments like HHIs and anti-PD1 therapies. The treatment involves injections of L19IL2/L19TNF directly into the tumors. Researchers want to see how well this treatment shrinks the tumors (Best Overall Response Rate) over a period of up to 160 weeks. The study is currently recruiting about 92 participants aged 18 and older. There are no specific biomarkers required to join.
- Study design
- This is an open-label, single-arm study, meaning all participants receive the same treatment and both you and your doctors will know what treatment you are receiving. It plans to enroll 92 participants.
- What's involved
- You would receive weekly injections of L19IL2/L19TNF into your tumors for up to 4 weeks, with a possible second 4-week course. You will have tumor assessments at specific weeks for up to three years.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for overall survival (how long you live) after treatment, with phone or documented contact every 6 months until death, withdrawal, or study completion.
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NCT07227870
L19IL2/TNF in Patients With Basal Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentPhilogen S.p.A.
~92 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:L19IL2/L19TNF
At a glance
Recruiting sites
15 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate (BORR)
Measured over From enrollment up to a maximum of 160 weeks after the start of treatment
Conditions
Where it's being run
18 sites across 9 statesGermany7
Italy4
Florida1
Georgia1
New York1
Ohio1
Texas1
Greece1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients must have histologically documented, locally advanced BCC.
Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.
Patients must have locally advanced BCC that has progressed on or cannot tolerate HHIs and anti-PD1 treatments assessed by a local multidisciplinary tumor board.
Patients with nodal, regional or in transit injectable BCC lesions.
Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.
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 ≤ 2.
Hemoglobin \> 10.0 g/dL.
Platelets \> 100 x 109/L.
ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.
Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion
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 cutaneous squamous cell carcinoma of the skin (surgically removed at least 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, immunotherapy.
Presence of visceral metastasis.
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.
Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
Pregnancy or breast-feeding.
Ischemic peripheral vascular disease (Grade IIb-IV).
Severe diabetic retinopathy.
Recovery from major trauma including surgery within 4 weeks prior to enrollment.
Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
What this trial measures
- Best Overall Response Rate (BORR)From enrollment up to a maximum of 160 weeks after the start of treatment
Best Overall Response Rate (BORR) as defined by the BCC-RECIST-like criteria according to an Independent Central Review (ICR).