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Testing bifikafusp alfa and onfekafusp alfa injections in patients with locally advanced basal cell carcinoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at basal cell carcinoma, which is a type of skin cancer that has grown locally in one area of the body but has not spread to other parts. The study will test three different treatment approaches using medications called Darleukin (also known by its code name L19IL2) and Fibromun (also known by its code name L19TNF). These medications will be given either alone or in combination with each other. The treatments will be injected directly into the skin tumor, which is called intralesional injection, meaning the medication is placed right into the affected area rather than given through the bloodstream.

The purpose of this study is to find out how well these treatments work for people with this type of skin cancer who cannot have surgery or radiation therapy, or who have chosen not to have these treatments. The study will compare the different treatment options to see which one is most effective. People taking part in this study will have a skin cancer that has either come back after previous surgeries or is in a location where surgery would cause significant problems or changes to appearance.

During the study, participants will receive injections of one of the study medications directly into their skin tumor over a period of several weeks. The study team will monitor how the tumor responds to treatment and will check for any side effects. The treatments are given in cycles, and participants will be followed to see how well the medication works at controlling or shrinking the cancer. The study is designed to help doctors understand whether these new treatment options could be helpful for people with this type of skin cancer who need alternatives to surgery or radiation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    Upon joining the study, you will be randomly assigned to one of the treatment groups. This means a computer system will determine which treatment you will receive.

    The possible treatments are: bifikafusp alfa (also called L19IL2), onfekafusp alfa (also called L19TNF), or a combination of both medications.

    All medications will be given as intralesional injections, which means the medicine will be injected directly into your skin tumor.

  2. Step 2

    Treatment administration

    You will receive injections of the assigned medication directly into your basal cell carcinoma lesion. Basal cell carcinoma is a type of skin cancer.

    The medication is a solution for injection, which will be administered into the tumor area on your skin or just beneath the skin surface.

    The specific dosage, frequency, and duration of treatment will be determined by the study protocol for your assigned treatment group.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your tumor will be monitored to evaluate how it responds to the treatment.

    Your overall health status and any side effects will be assessed regularly during the treatment period.

    The study will measure the effectiveness of the medication in treating your locally advanced basal cell carcinoma.

  4. Step 4

    Study completion

    The study is estimated to continue until December 2030.

    You will continue to receive the assigned treatment and undergo assessments according to the study schedule until the completion of your participation in the trial.

Who can join the trial?

17 criteria

  • You must have basal cell carcinoma (a type of skin cancer) that is locally advanced, meaning it has grown in the area where it started but has not spread to distant parts of the body or nearby lymph nodes (small bean-shaped organs that are part of your immune system).
  • Your cancer must be confirmed by histology, which means a sample of your tissue was examined under a microscope by a specialist.
  • Your tumor must be suitable for intratumoral injection, which means the study medicine can be injected directly into the tumor.
  • You must not be eligible for surgery (an operation to remove the cancer) or radiation therapy (treatment using high-energy rays), or you have refused these treatments, as determined by a team of cancer specialists.
  • Your ECOG Performance Status or WHO Performance Status must be 1 or lower. This is a score that measures how well you can perform your daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work.
  • Your hemoglobin level (a protein in your red blood cells that carries oxygen) must be greater than 10.0 grams per deciliter.
  • Your platelet count (cells that help your blood clot) must be greater than 100 times 10 to the power of 9 per liter.
  • Your liver enzyme levels (ALT, AST, GGT) and lipase (an enzyme made by your pancreas) must be no more than 1.5 times the upper limit of normal.
  • Any side effects from previous treatments (except hair loss) must have improved to Grade 1 or lower according to a standard scale used to measure side effects.
  • You must have previously received radiation therapy for your cancer, unless it was not appropriate for you or not safe.
  • You must have at least one tumor that can be injected and measured on your skin or just under your skin.
  • You must not have received prior treatment with checkpoint inhibitors, which are a type of medicine that helps your immune system fight cancer.
  • You may have had surgery or radiation therapy in the past.
  • Your cancer may have come back in the same place after two or more surgeries, and removing it completely is not likely to be possible.
  • Surgery may be expected to cause significant harm or changes to your appearance.
  • You may have medical conditions that make surgery risky or difficult.
  • Any other medical reasons that make treatment unsuitable must be discussed with the study doctor before you can join.

Who cannot join the trial?

4 criteria

  • The study information provided does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, the research team will need to review your complete medical history to determine if you meet all requirements for participation
  • General factors that often prevent participation in clinical trials may include having other serious medical conditions, taking certain medications, being pregnant or breastfeeding, or having had recent treatments that could interfere with the study
  • Each clinical trial has specific rules about who can and cannot join, and these details would need to be discussed directly with the study doctors
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Investigated drugs

L19IL2 is an experimental medication being tested in this study. It is designed to be injected directly into the tumor (intralesional injection) to help treat basal cell carcinoma, which is a type of skin cancer. This medication combines a targeted protein (L19) with interleukin-2 (IL2), a substance that helps activate the body's immune system to fight cancer cells.

L19TNF is another experimental medication being evaluated in this trial. Like L19IL2, it is also injected directly into the tumor. This medication combines the same targeted protein (L19) with tumor necrosis factor (TNF), which is a different type of substance that can help destroy cancer cells and affect the blood vessels that feed the tumor.

The study also tests a combination treatment using both L19IL2 and L19TNF together. This combination approach uses both medications injected into the tumor to see if using them together works better than using either one alone for treating basal cell carcinoma.

What is already known about the treatment

  • L19IL2

    L19IL2 is an experimental medication currently being studied in clinical trials for the treatment of locally advanced basal cell carcinoma, a type of skin cancer. It is administered through direct injection into the tumor (intralesional injection) and works by combining a targeted antibody fragment (L19) that finds cancer cells with interleukin-2 (IL2), a substance that activates the body's immune system to attack the tumor. This medication belongs to a class of drugs called immunocytokines, which are designed to deliver immune-stimulating molecules directly to cancer tissue while minimizing effects on healthy cells.

  • L19TNF

    L19TNF is an investigational drug being tested in clinical trials for treating locally advanced basal cell carcinoma, a form of skin cancer that has grown deeper into the skin. The medication is given by injection directly into the affected area and combines a targeting molecule (L19) that recognizes cancer blood vessels with tumor necrosis factor (TNF), a protein that can destroy cancer cells and cut off their blood supply. As an immunocytokine therapy, it is designed to concentrate the cancer-fighting effects specifically at the tumor site, reducing potential side effects throughout the rest of the body.

Investigated diseases

Basal Cell Carcinoma – Basal cell carcinoma is the most common type of skin cancer that develops in the basal cells, which are found in the deepest layer of the skin. This cancer typically appears as a slightly transparent bump on the skin, though it can take other forms. It most often occurs on areas of skin that are frequently exposed to the sun, such as the head and neck. The cancer grows slowly and rarely spreads to other parts of the body. Locally advanced basal cell carcinoma refers to cases where the tumor has grown larger or deeper into nearby tissues. If left untreated, it can grow into nearby areas and cause damage to skin, tissue, and bone.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523229-16-00Protocol codePHL19IL2TNFCOMB04/24Estimated enrolment188 patientsSponsorPhilogen S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).