Angiosarcoma non-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 investigating treatment options for patients with soft tissue sarcoma, a type of cancer that develops in soft tissues like muscles and fat. Angiosarcoma is one of the specific types of soft tissue sarcoma included in this study. The trial focuses on patients whose cancer has spread to other parts of the body or who did not respond well to previous treatments.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Diagnosed with advanced or metastatic soft-tissue sarcoma, including angiosarcoma, that either did not respond to previous anthracycline treatment or where anthracyclines cannot be used for medical reasons
• High-grade soft tissue sarcoma (grade 2-3) confirmed by testing
• Tumor tests positive for CD13, a specific protein marker, with a score of 1 or higher
• 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 (ECOG Performance Status of 2 or less)
• For women of childbearing potential: negative pregnancy test and commitment to use effective birth control during the study and for 3 months afterward
• For men: commitment to 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
• Negative test result for 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 tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time compared to trabectedin alone. Participants are randomly assigned to one of two treatment 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 trial follows a structured approach over several steps. After initial evaluation confirms eligibility and CD13 positivity through laboratory testing, patients are assigned to a treatment group. Treatment administration continues for up to 360 days or until the disease progresses. Throughout the study, regular medical examinations and imaging tests monitor how the cancer responds to treatment. After treatment completion, participants continue to be monitored according to the study schedule, with the entire study expected to continue until March 2029.

Investigational drugs:

Trabectedin is a cancer medication used to treat soft tissue sarcoma. 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 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 cancer treatment more effective by keeping the medication concentrated where it is needed most.

Summary

Currently, there is only one ongoing clinical trial specifically including patients with non-metastatic angiosarcoma. This trial is being conducted in Germany and represents an important research effort for patients with soft tissue sarcoma, including angiosarcoma, who have not responded to first-line treatment. The study focuses on comparing single-agent trabectedin therapy with a combination approach using trabectedin and the experimental drug tTF-NGR. A key feature of this trial is the requirement for CD13 positivity, a specific protein marker that may help identify patients most likely to benefit from this targeted treatment approach. The trial is designed to evaluate whether the addition of tTF-NGR can improve treatment outcomes by concentrating chemotherapy within the tumor tissue.