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RecruitingRare disease

Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial studies a treatment for soft tissue sarcoma, a type of cancer that develops in soft tissues like muscles and fat. The study focuses on patients whose cancer has spread to other parts of the body (metastatic) or who did not respond well to previous treatments. The trial compares two treatment approaches: one using only trabectedin (a chemotherapy medication) and another combining trabectedin with tTF-NGR (an experimental drug).

The study aims to determine if adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. Both medications are given through an intravenous infusion directly into the bloodstream. The experimental drug tTF-NGR is designed to concentrate the chemotherapy medication inside the tumor.

During the study, participants receive treatment for up to 360 days. Some patients will receive only trabectedin, while others will receive both trabectedin and tTF-NGR. Regular medical examinations and imaging tests will be performed to monitor how the cancer responds to the treatment. The study focuses on patients whose tumors show a specific characteristic called CD13 positivity, which is determined through laboratory testing.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and preparation

    Your doctor will confirm if you have soft tissue sarcoma that meets the study criteria

    A test will check if your tumor has CD13 positivity (a specific protein marker)

    You will undergo imaging tests to measure your tumor

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Treatment with trabectedin alone

    Group 2: Treatment with trabectedin plus tTF-NGR

  3. Step 3

    Treatment administration

    You will receive your assigned treatment through intravenous infusion (directly into your vein)

    Both medications will be given as a solution for infusion

    Treatment will continue until your disease progresses or other stopping criteria are met

  4. Step 4

    Monitoring during treatment

    Regular imaging tests will track your tumor's response to treatment

    Your overall health status will be monitored throughout the study

    If you are of childbearing potential, monthly pregnancy tests will be required

  5. Step 5

    Follow-up period

    After treatment completion, you will need to use effective contraception for 3 months (women) or 5 months (men)

    Your health status will continue to be monitored according to the study schedule

    The study is expected to continue until March 2029

Who can join the trial?

12 criteria

  • Age between 18 and 75 years
  • Must provide signed and dated informed consent to participate in the study
  • Must be able to attend scheduled visits, follow treatment plan, and complete required tests
  • Have advanced or metastatic soft-tissue sarcoma (cancer that begins in soft tissues) that either: - Did not respond to previous treatment with anthracycline medications - Or cannot take anthracycline medications due to medical reasons
  • Must have confirmed high-grade soft tissue sarcoma (grade 2-3) of specific types, such as: - Liposarcoma (several types) - Fibrosarcoma - Leiomyosarcoma - Rhabdomyosarcoma - Angiosarcoma - Synovial sarcoma - Undifferentiated sarcoma
  • Must test positive for CD13 (a specific protein marker) with a score of 1 or higher
  • Must have at least one measurable tumor that has not been previously treated with radiation
  • Life expectancy of at least 3 months
  • ECOG Performance Status of 2 or less (ability to carry out daily activities)
  • Must be able to take the medication trabectedin
  • For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control during the study and for 3 months after
  • For men: - Must use birth control methods for 5 months after the last treatment

Who cannot join the trial?

15 criteria

  • Age below 18 or above 75 years
  • No confirmed diagnosis of soft-tissue sarcoma (a type of cancer that develops in soft tissues)
  • No previous treatment with anthracycline therapy (a type of chemotherapy medication)
  • Negative test result for CD13 (a specific protein marker on cells)
  • Current pregnancy or breastfeeding
  • Absence of measurable or evaluable disease
  • Previous treatment with trabectedin (a type of chemotherapy medication)
  • Severe heart conditions
  • Severe liver problems
  • Severe kidney problems
  • Active uncontrolled infections
  • Other active cancers requiring treatment
  • Known allergic reactions to the study medications
  • Unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • Trabectedin

    is a cancer medication used to treat soft tissue sarcoma (a type of cancer that develops in soft tissues like muscles and fat). It works by interfering with cancer cell growth and division. This medication is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively.

  • tTF-NGR

    is an experimental therapy designed to work together with Trabectedin. It's a protein that targets blood vessels in tumors and is intended to help trap the cancer medication (Trabectedin) inside the tumor. This combination approach aims to make the cancer treatment more effective by keeping the medication concentrated where it's needed most.

What is already known about the treatment

  • Trabectedin

    A marine-derived anti-cancer medication administered through intravenous infusion, primarily used in the treatment of soft tissue sarcoma after failure of first-line anthracycline therapy. The drug works by binding to DNA and interfering with cell division, transcription, and DNA repair mechanisms in cancer cells, effectively stopping tumor growth. Trabectedin belongs to the class of antineoplastic agents and is currently approved for clinical use in patients aged 18-75 years with metastatic or refractory soft tissue sarcoma who either failed previous treatments or have contraindications to anthracyclines.

  • tTF-NGR

    An experimental therapeutic compound designed to work in combination with Trabectedin, aimed at enhancing the effectiveness of cancer treatment in soft tissue sarcoma patients. This targeted agent works by helping to trap Trabectedin inside the tumor tissue, potentially increasing its local concentration and therapeutic effect. The drug is currently being investigated in phase III clinical trials as a combination therapy with Trabectedin for patients with metastatic and/or refractory soft tissue sarcoma.

Investigated diseases

  • Soft Tissue Sarcoma

    A rare type of cancer that develops in soft tissues of the body, including muscles, tendons, fat, blood vessels, nerves, and deep skin tissues. It can occur in any part of the body, though it most commonly appears in the arms, legs, and abdomen. The disease typically begins as a painless lump that grows over time. As the disease progresses, it can spread (metastasize) to other parts of the body, particularly to the lungs. Soft tissue sarcomas comprise many different subtypes, each behaving differently depending on their location and cell type of origin.

  • Metastatic Soft Tissue Sarcoma

    An advanced stage of soft tissue sarcoma where cancer cells have spread from their original location to other parts of the body. In this stage, tumors develop in distant organs or tissues, most commonly affecting the lungs, but can also appear in the liver or bones. The disease at this stage typically manifests as multiple tumors in different body locations. The metastatic process occurs when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to form new tumors elsewhere.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516392-33-00Protocol codeWWU19_0007Estimated enrolment126 patientsSponsorUniversitaet Muenster

sourced from the EU Clinical Trials Register and site verification

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