INTERNATIONAL: Trabectedin Alone Versus Trabectedin With TTF-NGR InMetastatic Or Refractory Soft Tissue Sarcoma
Trial ID: NCT05997970
Phase: Phase 2
Status: Recruiting
Last Update Posted: Please verify directly on ClinicalTrials.gov
Eligibility: Adults aged 18 to 75 with advanced or metastatic high-grade soft tissue sarcoma, including synovial sarcoma, whose cancer did not respond to or who cannot tolerate anthracycline chemotherapy. Tumors must test positive for CD13 (a specific protein marker) with a score of 1 or higher, and patients must have at least one measurable lesion not previously treated with radiation.
Overview: This Phase 2 trial compares trabectedin alone versus trabectedin combined with tTF-NGR, an investigational therapy designed to target tumor blood vessels and concentrate drug delivery within the tumor. Participants are randomly assigned to one of two treatment groups and receive treatment by intravenous infusion for up to 360 days. Regular imaging tests monitor tumor response throughout the study. The study is expected to run until March 2029.
Preliminary Effectiveness: Trabectedin has demonstrated activity in soft tissue sarcoma including synovial sarcoma. tTF-NGR is an investigational approach aimed at improving treatment precision by concentrating therapy within the tumor. This study will determine whether the combination offers added benefit over trabectedin alone. No results have been posted at this time.
Treatment Centers: Germany