Phase III Study of Disitamab Vedotin and Trastuzumab Combination Therapy for Advanced HER2-Positive Gastric and Gastroesophageal Junction Cancer After Previous Treatment Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining Disitamab Vedotin and trastuzumab to treat advanced HER2-positive gastric and gastroesophageal junction tumors. This Phase III clinical trial focuses on patients who have previously undergone systemic therapy for their cancer. The study aims to improve treatment outcomes by overcoming limitations in drug penetration into tumor tissue and exploring new therapeutic options for this specific patient population. The study involves a combination therapy where Disitamab Vedotin is given at a dose of 2.5 mgkg by intravenous infusion on day 1 every two weeks, while trastuzumab is administered at doses determined through a dose-finding design, also every two weeks. The trial includes an initial dose exploration phase followed by a dose expansion phase at the recommended dose. This open-label, single-arm study evaluates how this combination therapy works in patients with HER2-positive tumors. Participants will be monitored for their tumor response over 12 months using objective response rate as the primary measure. Additional outcomes include overall survival up to 36 months, progression-free survival, disease control rate, and the incidence of serious treatment-related side effects. Patients will undergo regular assessments including scans and lab tests to evaluate treatment effects and safety throughout the study period.

Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens