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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hwymamty Dp Lr Sanjr Cdqj I Snok Pve	Barcelona	Spain
Fimhdbxsd Pyiy Ls Irrgwpiqbrjca Beratuqyc Dcr Hkpcrtja Utilheqbgqkca Lb Pna	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	29.05.2023

Trial locations

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.

Investigated diseases:

Soft tissue sarcoma

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.

Epithelioid Sarcoma – A slow-growing soft tissue cancer that typically starts in soft tissue under the skin of a finger, hand, forearm, or foot. It often appears as a small, firm growth or lump.

Angiosarcoma – A cancer that forms in the lining of blood vessels and lymph vessels. It can develop in any area of the body but often occurs in the skin, breast, liver, and spleen.

Uterine Sarcoma – A cancer that develops in the muscle or supporting tissues of the uterus. It begins in the muscle cells or connective tissue of the uterus.

Trial ID:

2024-510877-67-00

Protocol code:

Geis-74

NCT ID:

NCT05809830

Trial Phase:

Phase II and Phase III (Integrated)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?