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Study on L19TNF and Doxorubicin for Patients with Advanced or Metastatic Soft Tissue Sarcoma

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called soft tissue sarcoma, which is a cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. The study is specifically looking at cases where the cancer cannot be removed by surgery or has spread to other parts of the body, known as unresectable or metastatic soft tissue sarcoma. The trial is testing a new treatment combination to see if it can help patients live longer without the cancer getting worse. This new treatment combines a drug called doxorubicin, which is commonly used to treat this type of cancer, with a new experimental drug known by its code name L19TNF, which is a fusion of a human antibody and a protein that targets tumors.

The purpose of the study is to find out if the combination of L19TNF and doxorubicin is more effective than using doxorubicin alone. Participants in the study will receive either the combination of the two drugs or just doxorubicin. Some participants may receive a placebo, which is a substance with no active drug, to help compare the effects of the treatment. The study will involve regular visits to the clinic for treatment and monitoring, which includes physical exams and laboratory tests to check the safety and effectiveness of the treatment.

The trial will continue for a period of time to gather enough information to determine the benefits and risks of the new treatment combination. The main goal is to see if the new treatment can help patients live longer without their cancer getting worse, which is referred to as progression-free survival. The safety of the treatment will also be closely monitored throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Tests are performed to ensure the presence of advanced or metastatic soft tissue sarcoma that cannot be treated with surgery or radiotherapy.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of two medications: Fibromun and Doxorubicin.

    Fibromun contains the active substance onfekafusp alfa, and Doxorubicin is provided as a 2 mg/ml solution for injection.

    Both medications are administered through an intravenous infusion, which means they are given directly into a vein.

  3. Step 3

    Treatment schedule

    The treatment involves a combination of L19TNF (Fibromun) and Doxorubicin as the first-line therapy.

    The specific dosage and frequency of administration are determined by the study protocol and the healthcare team overseeing the trial.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    This includes physical examinations, laboratory tests, and imaging studies to measure the size of the tumor and evaluate progression-free survival.

  5. Step 5

    Safety assessments

    Safety assessments are performed to monitor for any adverse events or side effects related to the treatment.

    These assessments include standard laboratory tests, such as blood tests and urine analysis, as well as evaluations of vital signs and physical health.

  6. Step 6

    End of treatment

    The treatment phase continues until the study's end date or until it is determined that the treatment is no longer effective or safe.

    The estimated end date for the trial is December 31, 2025.

Who can join the trial?

9 criteria

  • Age between 18 and 75 years.
  • Must have a type of cancer called advanced unresectable and/or metastatic high-grade soft tissue sarcoma. This means the cancer cannot be removed by surgery and has spread to other parts of the body. Certain types of sarcoma are not allowed in the study.
  • Must have at least one tumor that can be measured using a special scan called computed tomography (CT). This tumor should not have been treated with radiation before.
  • Must have a life expectancy of at least 3 months.
  • Must have an ECOG score of 2 or less. ECOG is a scale used to assess how well a patient can perform daily activities.
  • Must have a negative test for HIV, HBV (Hepatitis B), and HCV (Hepatitis C). If previously exposed to HBV, a negative test for HBV-DNA is required. For HCV, a negative test for HCV-RNA is needed if the antibody test is positive.
  • Female patients who can have children must have a negative pregnancy test and agree to use effective birth control methods during the study and for six months after the last treatment. Male patients must agree to use two forms of birth control during the study and for four months after the last treatment.
  • Must sign a document called informed consent to show they understand the study and agree to participate.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.

Who cannot join the trial?

3 criteria

  • Patients who have a type of cancer called unresectable or metastatic soft tissue sarcoma cannot participate. This means the cancer cannot be removed by surgery or has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
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Investigated drugs

  • Doxorubicin

    is a chemotherapy medication used to treat various types of cancer, including soft tissue sarcoma. It works by slowing or stopping the growth of cancer cells. In this trial, doxorubicin is used as a standard treatment to compare its effectiveness when used alone versus in combination with another therapy.

  • L19TNF

    is a tumor-targeting human antibody-cytokine fusion protein. It is designed to specifically target and bind to cancer cells, delivering a cytokine called TNF (tumor necrosis factor) directly to the tumor. This targeted approach aims to enhance the immune system's ability to attack the cancer cells. In this trial, L19TNF is combined with doxorubicin to see if it improves the treatment outcomes for patients with advanced or metastatic soft tissue sarcoma.

What is already known about the treatment

  • Doxorubicin

    Doxorubicin is administered intravenously and is widely used in cancer treatment. It is a well-established chemotherapy drug, frequently mentioned in medical literature for its effectiveness against various cancers, including soft tissue sarcoma. The main therapeutic indication for doxorubicin is the treatment of different types of cancer, particularly those that are advanced or metastatic. At the molecular level, doxorubicin works by intercalating DNA, which disrupts the replication of cancer cells, leading to cell death. It is classified as an anthracycline antibiotic in pharmacology.

  • L19TNF

    L19TNF is administered intravenously and is currently under investigation in clinical trials. It is a novel therapeutic agent being studied for its potential to treat advanced or metastatic soft tissue sarcoma. The main therapeutic indication is its use in combination with doxorubicin to enhance treatment efficacy. L19TNF is a fusion protein that targets tumors by combining a human antibody with a cytokine, specifically tumor necrosis factor (TNF), to selectively attack cancer cells. It is classified as a targeted therapy in pharmacology.

Investigated diseases

Unresectable or Metastatic Soft Tissue Sarcoma – This is a type of cancer that begins in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. When the sarcoma is unresectable, it means it cannot be removed completely through surgery. If it is metastatic, the cancer has spread from its original site to other parts of the body. The disease can cause symptoms like swelling or a lump in the affected area, which may or may not be painful. As it progresses, it can affect the function of nearby organs or tissues. The growth and spread of the tumor can vary, and it may lead to further complications depending on the location and size of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512789-32-00Protocol codePH-L19TNFDOX2-03/16Estimated enrolment118 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).