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Study of bifikafusp alfa and onfekafusp alfa injected into tumors for patients with locally advanced basal cell carcinoma who progressed on or cannot tolerate systemic treatment

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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 a type of skin cancer called basal cell carcinoma that has spread locally and has gotten worse despite previous treatment or when patients could not tolerate standard therapy. Basal cell carcinoma is the most common form of skin cancer that usually grows slowly and rarely spreads to other parts of the body, but in some cases it can become more advanced and difficult to treat. The study will use two medications called Darleukin and Fibromun, which contain the active substances bifikafusp alfa and onfekafusp alfa. These medications will be given as injections directly into the tumor.

The purpose of this study is to see how well these two medications work when injected directly into the tumor in patients whose cancer has continued to grow or who could not tolerate previous treatments. The medications work by helping the body's immune system fight the cancer cells. During the study, patients will receive the treatment injections over a period of several weeks, and doctors will monitor how the tumors respond to the treatment.

Patients participating in this study will need to have at least one tumor that can be injected and measured. Before starting treatment and during the study, small tissue samples will be taken from the tumor to check how it is responding. The study will track changes in the size and appearance of the tumors to determine whether the treatment is helping. Regular check-ups and tests will be done to monitor both the effectiveness of the treatment and any side effects that may occur.

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 assessment and baseline procedures

    Upon entering the study, a tissue sample will be collected from a tumor through a core biopsy or excisional biopsy. A core biopsy involves removing a small cylinder of tissue using a hollow needle, while an excisional biopsy means removing a larger piece or the entire lesion.

    Blood tests will be performed to check hemoglobin levels (a protein in red blood cells that carries oxygen), platelet count (cells that help blood clot), and liver enzyme levels including ALT, AST, GGT, and lipase to ensure proper organ function.

    If applicable, a pregnancy test will be conducted to confirm that no pregnancy is present before starting treatment.

  2. Step 2

    Treatment phase with study medications

    The treatment involves two investigational medications: Fibromun (containing onfekafusp alfa) and Darleukin (containing bifikafusp alfa). These medications are also referred to as L19IL2 and L19TNF.

    Both medications will be administered as a solution for injection directly into the tumor. This method is called intratumoral administration or intralesional use, meaning the medication is injected into the tumor tissue itself.

    The specific dosage, frequency, and duration of treatment are not specified in the available information and will be determined by the study protocol.

  3. Step 3

    Monitoring and follow-up assessments

    During the study, the tumor will be regularly assessed to measure its response to treatment. This will be done according to BCC-RECIST-like criteria, which are standardized methods for evaluating how tumors respond to treatment.

    An Independent Central Review will be conducted, meaning specialists not directly involved in the treatment will independently evaluate the tumor response to ensure objective assessment.

    If an objective response (tumor shrinkage) or stable disease (tumor not growing) is observed, another tissue sample through biopsy will be required to confirm the results.

    Regular monitoring will continue throughout the study to track the effectiveness of the treatment and any side effects that may occur.

  4. Step 4

    Contraception requirements during the study

    If applicable, two acceptable methods of contraception must be used simultaneously throughout the study period to prevent pregnancy.

    This requirement applies to male patients whose partners are of childbearing potential, as well as to female patients who are able to become pregnant.

Who can join the trial?

11 criteria

  • You must have locally advanced basal cell carcinoma, which is a type of skin cancer that has grown deeper into the skin or surrounding areas, confirmed by a tissue sample examined under a microscope
  • You must be between 18 and 100 years old
  • You must have at least one skin or under-the-skin tumor that can be injected with the study drug and measured
  • Your cancer must have gotten worse despite previous standard treatments or you were unable to tolerate these treatments, as determined by a team of cancer specialists
  • You may have cancer that has spread to nearby lymph nodes, which are small bean-shaped organs that help fight infection, or to areas between the original tumor and lymph nodes
  • You must be willing to provide tissue samples from your tumor through a needle or surgical biopsy at the beginning of the study and later to check how the treatment is working
  • If you are a male patient with a female partner who can become pregnant, you must agree to use two acceptable methods of birth control at the same time
  • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study
  • Your ECOG performance status must be 2 or less, which is a score that measures how the disease affects your daily living abilities, with lower numbers meaning you are more active
  • Your blood tests must show: hemoglobin (the protein in red blood cells that carries oxygen) greater than 10.0 grams per deciliter, platelets (blood cells that help with clotting) greater than 100 thousand per microliter, and liver enzymes and other blood markers no more than 1.5 times the upper normal limit
  • Any side effects from previous cancer treatments, except hair loss, must have improved to a mild level or completely resolved

Who cannot join the trial?

14 criteria

  • Patients whose basal cell carcinoma (a type of skin cancer) cannot be treated with injection directly into the tumor
  • Patients who have not yet tried or have not failed systemic treatment (medication that travels through the bloodstream to reach cancer cells throughout the body)
  • Patients who can tolerate systemic treatment and have not experienced problems with it
  • Patients whose cancer has not grown or spread despite previous treatment
  • Children and adolescents under 18 years of age
  • Pregnant women or women who are breastfeeding
  • Patients with severe heart problems or heart disease
  • Patients with active infections that are not controlled
  • Patients with other cancers that are currently active or not fully treated
  • Patients with autoimmune diseases (conditions where the body's defense system attacks its own healthy cells)
  • Patients who are taking medications that suppress the immune system (the body's natural defense against disease)
  • Patients with severe kidney or liver problems
  • Patients who have had an allergic reaction (a negative response by the body's immune system) to similar treatments in the past
  • Patients who are participating in another clinical trial at the same time
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Investigated drugs

  • L19IL2

    is an experimental cancer treatment that combines a special protein called L19 with interleukin-2 (IL2). The L19 part helps direct the medication specifically to tumor tissue, while the IL2 part works to activate your immune system to fight cancer cells. In this trial, it is given as an injection directly into the tumor.

  • L19TNF

    is an experimental cancer treatment that combines a special protein called L19 with tumor necrosis factor (TNF). The L19 part helps target the medication directly to tumor tissue, while the TNF part works to destroy cancer cells and cut off their blood supply. In this trial, it is given as an injection directly into the tumor.

What is already known about the treatment

  • L19IL2

    L19IL2 is an experimental biological medication administered through direct injection into tumors (intratumoral injection) that is currently being studied in clinical trials for treating advanced basal cell carcinoma, a type of skin cancer. This medication works by combining a targeted antibody fragment (L19) that finds and attaches to specific markers on tumor blood vessels with interleukin-2 (IL2), a substance that activates the body's immune system to attack cancer cells. It belongs to a class of drugs called immunocytokines, which are designed to deliver immune-stimulating substances directly to the tumor site, potentially reducing side effects while enhancing the body's natural cancer-fighting response.

  • L19TNF

    L19TNF is an investigational biological drug given by injection directly into tumors (intratumoral injection) that is being evaluated in clinical research for patients with locally advanced basal cell carcinoma who have not responded to or cannot tolerate standard treatments. This medication combines the L19 antibody fragment, which specifically targets and binds to tumor blood vessels, with tumor necrosis factor (TNF), a powerful protein that can destroy cancer cells and damage the blood supply that feeds tumors. As an immunocytokine medication, it is designed to concentrate the cancer-fighting effects precisely at the tumor location, aiming to improve treatment effectiveness while minimizing potential harm to healthy tissues throughout the body.

Investigated diseases

Basal Cell Carcinoma – Basal cell carcinoma is a type of skin cancer that begins in the basal cells, which are found in the deepest layer of the outer skin. It typically appears as a slightly transparent bump on the skin, though it can take other forms. The cancer grows slowly and usually occurs on areas of skin that are frequently exposed to the sun, such as the face and neck. Locally advanced basal cell carcinoma refers to cases where the cancer has grown larger or deeper into nearby tissues. The tumor can gradually damage surrounding skin and underlying structures if it continues to grow. This form of skin cancer rarely spreads to other parts of the body but can cause significant local tissue damage over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523230-77-00Estimated enrolment145 patientsSponsorPhilogen S.p.A.

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