Fibrosarcoma metastatic Trials in 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

This clinical trial is designed for patients with metastatic fibrosarcoma and other types of soft tissue sarcoma whose cancer has spread to other parts of the body or has not responded to previous treatments. The study compares two treatment approaches to determine which works better at keeping the cancer under control.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Confirmed diagnosis of advanced or metastatic soft tissue sarcoma, including fibrosarcoma, that did not respond to previous anthracycline medications or where anthracycline treatment is not medically appropriate
• The cancer must be high-grade (grade 2-3)
• Tumor tissue must test positive for a protein marker called CD13
• At least one measurable tumor that has not been previously treated with radiation
• Life expectancy of at least 3 months
• Ability to carry out daily activities with limited assistance
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months afterward
• Men must use birth control methods for 5 months after treatment ends

Main exclusion criteria:

• Age below 18 or above 75 years
• No previous treatment with anthracycline chemotherapy
• Tumor tissue that tests negative for the CD13 protein marker
• Current pregnancy or breastfeeding
• Previous treatment with trabectedin
• Severe heart, liver, or kidney problems
• Active uncontrolled infections
• Other active cancers requiring treatment
• Known allergic reactions to the study medications
• Participation in another clinical trial within the past 30 days

Focus and goal of the trial:

The study aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin chemotherapy helps control the cancer better than trabectedin alone. Participants are randomly assigned to one of two groups: one receiving only trabectedin and another receiving both trabectedin and tTF-NGR. Both medications are given through an intravenous infusion directly into the bloodstream. The treatment can continue for up to 360 days, depending on how well the cancer responds and how the patient tolerates the medications.

The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective by concentrating it where it is needed most. The study focuses specifically on patients whose tumors show CD13 positivity, a characteristic determined through laboratory testing.

Throughout the study, participants undergo regular medical examinations and imaging tests to monitor how the cancer responds to treatment. After treatment completion, follow-up continues with ongoing health monitoring. The study is expected to continue until March 2029.

Investigational drugs:

Trabectedin is a cancer medication that works by interfering with cancer cell growth and division. It is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively. This medication is administered through intravenous infusion.

tTF-NGR is an experimental therapy designed to work together with trabectedin. It is a protein that targets blood vessels in tumors and is intended to help trap the cancer medication inside the tumor. This combination approach aims to make the treatment more effective by keeping the medication concentrated at the tumor site.