Study of Becotatug Vedotin MRG003 and Epirubicin as Pre-Surgery Treatment for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma

What this Trial Is About

Researchers are evaluating the combined use of Becotatug vedotin MRG003 and epirubicin as a neoadjuvant therapy for patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma SNACC. This prospective, multicenter, single-arm, open-label phase II study aims to determine if this combination can achieve a sufficient objective response rate to allow for radical surgery or better disease control. The study also includes a translational research component to analyze tumor biopsies and correlate drug sensitivity with clinical outcomes. Participants receive MRG003 at 2.0 mgkg intravenously and epirubicin at 75 mgm intravenously on day 1 of each 21-day cycle for a total of 3 cycles. The primary outcome is the objective response rate assessed about 21 days after the third cycle. Secondary outcomes include safety, surgical conversion rate, disease control, progression-free and overall survival, and pathological response. Tumor biopsies are used to develop patient-derived organoid models for drug sensitivity testing. During the study, participants undergo assessments of tumor response, safety monitoring up to 30 days after the last dose, and surgical evaluation within 4 weeks after neoadjuvant therapy. Long-term follow-up includes monitoring progression-free and overall survival every 3 months for 2 years, then every 6 months up to 5 years. The total study duration is approximately 48 months, including enrollment, treatment, and follow-up. An independent board reviews safety after 20 participants enroll.

A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma