Angiosarcoma 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 compares two treatment approaches for patients with advanced soft tissue sarcoma, including angiosarcoma, whose cancer has either spread to other parts of the body or has not responded to previous treatments. The study examines whether combining trabectedin with an experimental drug called tTF-NGR works better than using trabectedin alone.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Confirmed diagnosis of high-grade soft tissue sarcoma, including angiosarcoma
• Advanced or metastatic disease that did not respond to previous anthracycline treatment, or patients who cannot take anthracycline medications
• Tumor must test positive for CD13, a specific protein marker
• At least one measurable tumor that has not been treated with radiation
• Life expectancy of at least 3 months
• Able to carry out daily activities with minimal assistance
• Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 3 months after
• Men must use birth control methods for 5 months after the last treatment

Main exclusion criteria:

• Age below 18 or above 75 years
• No previous treatment with anthracycline chemotherapy
• Tumor tests negative for CD13
• 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 trial aims to determine whether adding tTF-NGR to standard trabectedin treatment helps control cancer growth for a longer period. Participants are randomly assigned to receive either trabectedin alone or trabectedin combined with tTF-NGR. Both medications are given through intravenous infusion directly into the bloodstream. Treatment can continue for up to 360 days, and patients undergo regular medical examinations and imaging tests to monitor how the cancer responds. 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 anthracycline-based therapies, have not worked effectively. tTF-NGR is an experimental drug designed to target blood vessels in tumors. It is intended to help concentrate trabectedin inside the tumor, potentially making the treatment more effective by keeping the medication where it is needed most.