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Study of LB-100 plus doxorubicin compared to doxorubicin alone in adults with advanced soft tissue sarcomas as first-line treatment

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with soft tissue sarcomas, which are rare cancers that develop in soft tissues like muscles, tendons, and fat. The research examines two treatments: a combination of a new drug called LB-100 with doxorubicin (a chemotherapy medication), compared to using doxorubicin alone. The purpose is to determine if adding LB-100 to standard doxorubicin treatment improves outcomes for patients with advanced soft tissue sarcomas.

The study is divided into two phases. The first phase aims to find the safest and most effective dose of LB-100 when given with doxorubicin. The second phase compares how well patients do when treated with either the combination of both drugs or doxorubicin by itself. Both medications are given through an intravenous infusion (directly into a vein).

The research specifically looks at several types of soft tissue sarcomas, including undifferentiated pleomorphic sarcoma and leiomyosarcoma. Doctors will monitor how long patients live without their disease getting worse, track any side effects, and assess the overall survival of participants. They will also evaluate how the treatments affect patients' quality of life during the study.

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 qualification

    You will undergo initial health assessment including blood tests, heart function tests (showing heart ejection fraction ≥ 50%), and imaging tests

    If you are a woman who can become pregnant, you will need a pregnancy test within 7 days before starting

    A sample of your tumor tissue will be examined by specialists to confirm your diagnosis

  2. Step 2

    Medical measurements

    Your tumor will be measured using special imaging techniques

    Your overall physical condition will be assessed using the ECOG scale (a measure of daily activity ability)

    Laboratory tests will check your blood cell counts, liver function, kidney function, and blood sugar levels

  3. Step 3

    Treatment phase

    You will receive doxorubicin through an intravenous line

    Some participants will also receive an additional medication called LB-100

    The treatment will continue until either the disease progresses or side effects become too severe

    Regular monitoring of your heart function will occur throughout treatment

  4. Step 4

    Monitoring period

    Regular physical examinations and laboratory tests will track your health status

    Imaging tests will measure how your tumor responds to treatment

    You will complete quality of life questionnaires about your well-being

    Side effects will be monitored and recorded throughout the treatment

  5. Step 5

    Follow-up period

    After treatment ends, you will need to use effective contraception for 3 months

    Regular check-ups will continue to monitor your health status

    Your survival and disease status will be tracked over time

Who can join the trial?

16 criteria

  • Must be 18 years or older
  • Must provide written informed consent before any study procedures begin
  • Must have confirmed diagnosis of advanced soft tissue sarcoma (a type of cancer that begins in soft tissues) confirmed by central laboratory review
  • Must have a tumor tissue sample available for testing. If an older sample is not available, must agree to have a new biopsy taken within 28 days before starting the study
  • Must have tumors that can be measured using standard imaging techniques
  • Must have good physical function, scoring 0-1 on the ECOG scale (a scale that measures ability to perform daily activities)
  • Must never have received treatment with anthracyclines (a type of chemotherapy medication) before
  • Must have normal heart function with heart ejection fraction of 50% or higher (measured by heart scan)
  • Must have adequate blood test results, including:
    • Adequate white blood cell counts
    • Normal platelet levels
    • Acceptable liver function tests
    • Normal kidney function
    • Controlled blood sugar levels
    • Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study
    • Must not be pregnant or nursing
    • Both men and women who can have children must use effective birth control during the study and for 3 months after the last treatment

Who cannot join the trial?

13 criteria

  • Previous treatment with doxorubicin or other anthracycline drugs (a type of chemotherapy)
  • History of heart problems or reduced heart function, as doxorubicin can affect the heart
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • Pregnant or breastfeeding women
  • Serious active infections requiring treatment
  • Other types of cancer within the last 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Major surgery within 4 weeks before starting the study treatment
  • Known HIV (Human Immunodeficiency Virus) infection
  • Active hepatitis B or C infection
  • Severe liver or kidney problems
  • Inability to swallow oral medications
  • Any condition that would make it unsafe to participate in the study, as determined by the study doctor
  • Participation in another clinical trial within 4 weeks before starting this study
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Investigated drugs

LB-100 is an experimental drug being tested for cancer treatment. It is being studied in combination with other cancer medications to see if it can improve treatment outcomes for patients with soft tissue sarcomas. Doxorubicin is a chemotherapy medication commonly used to treat various types of cancer, including soft tissue sarcomas. It works by interfering with cancer cell growth and division. It belongs to a class of drugs called anthracyclines and is sometimes known by the brand name Adriamycin. The trial compares the effectiveness of using these two medications together versus using doxorubicin by itself, to see if the combination provides better results in treating advanced soft tissue sarcomas.

What is already known about the treatment

  • LB-100

    An investigational drug being studied in combination with doxorubicin for the treatment of advanced soft tissue sarcomas. This medication is currently in Phase I/II clinical trials to determine its maximum tolerated dose and effectiveness when combined with standard chemotherapy. The drug is being evaluated specifically for patients with various types of sarcomas, including undifferentiated pleomorphic sarcoma and leiomyosarcoma.

  • Doxorubicin

    A widely used chemotherapy medication administered intravenously to treat various types of cancer, including soft tissue sarcomas. It belongs to the anthracycline class of drugs and works by interfering with cancer cell DNA, preventing the cells from dividing and multiplying. This medication is considered a standard treatment option for advanced sarcomas and is being studied both alone and in combination with LB-100 to evaluate potential improvements in progression-free survival.

Investigated diseases

  • Undifferentiated Pleomorphic Sarcoma

    A type of soft tissue cancer that develops in the body's connective tissues. It can occur in any part of the body but most commonly affects the arms and legs. The tumor is made up of many different-looking cancer cells.

  • Leiomyosarcoma

    A rare cancer that grows in smooth muscle tissue. It typically develops in the walls of blood vessels, uterus, stomach, or intestines. The cancer cells in this type look similar to normal smooth muscle cells when viewed under a microscope.

  • Myxoid Liposarcoma

    A soft tissue cancer that develops from fat cells. It has a distinctive appearance with a mucus-like substance between the cancer cells. This type commonly occurs in the limbs, especially the thighs.

  • Myxofibrosarcoma

    A cancer that occurs in connective tissue, particularly in the limbs. It typically appears as a slow-growing, painless mass beneath the skin. The tumor contains both fibrous tissue and mucus-like material.

  • Synovial Sarcoma

    A soft tissue cancer that can develop anywhere in the body but often occurs near joints in the arms or legs. Despite its name, it doesn't actually arise from synovial tissue.

  • Fibrosarcoma

    A cancer that develops in fibrous tissue, which forms tendons and ligaments. It consists of malignant fibroblast cells that produce collagen.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase II/IIITrial ID2024-510877-67-00Protocol codeGeis-74Estimated enrolment157 patientsSponsorAsoc Grupo Espanol De Investigacion En Sarcomas

sourced from the EU Clinical Trials Register and site verification

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