Study of L19IL2, L19TNF, or L19IL2/TNF for Locally Advanced Basal Cell Carcinoma
This study is testing three different treatments for locally advanced basal cell carcinoma (a type of skin cancer that has grown deeper or spread to nearby tissues but not to distant parts of the body). You might be able to join if you have this type of cancer and cannot have surgery or radiation therapy, or choose not to. The treatments being studied are L19IL2, L19TNF, or a combination of L19IL2 and L19TNF, given as injections directly into the tumor. Researchers want to see how well these treatments shrink or get rid of the cancer. The study aims to enroll up to 180 participants. The current status of the study is unclear.
- Study design
- This is an open-label, randomized study, meaning you and your doctors will know which treatment you are receiving. Up to 180 participants will be randomly assigned to one of three treatment groups.
- What's involved
- You would receive injections into your tumor once a week for four weeks. You would have tumor assessments at weeks 8, 12, and 16, then every 8 weeks for the first year, and every 12 weeks for the second and third years.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, your tumor will be assessed for up to three years. If your tumor responds or stabilizes, a confirmation assessment will be done four weeks later.
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NCT07227350
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
Recruiting
PHASE2Ages 18+InterventionalTreatmentPhilogen S.p.A.
~180 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:L19IL2L19TNFL19IL2/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
Measured over from enrollment to week 16
Conditions
Where it's being run
18 sites across 9 statesGermany6
Italy4
Ohio2
Florida1
Georgia1
North Carolina1
Texas1
Greece1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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, vasectomized 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 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.
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 Ratefrom enrollment to week 16
Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.