A Phase 1b2 Open-Label Study of Disitamab Vedotin With Tucatinib in Solid Tumors Expressing HER2

What this Trial Is About

Researchers are evaluating the combination of disitamab vedotin and tucatinib in people with advanced or metastatic breast or gastric cancers that express the HER2 protein. These solid tumors, which start in organs like the breast or stomach, tend to grow quickly or spread, making treatment challenging. This Phase 2 clinical trial aims to test how safe and effective this combination therapy is, particularly for tumors that have HER2, which helps cancer cells grow faster and spread more easily. The study includes several phases a dose escalation phase to find the best dose of disitamab vedotin combined with tucatinib, followed by a dose optimization phase to assess safety and effectiveness at selected doses. After these phases, an expansion phase will evaluate this combination in four groups of participants with different HER2 expression levels and cancer types. Disitamab vedotin is given intravenously, while tucatinib is taken orally twice daily at 300 mg. Participants receive the combination therapy according to their assigned study group. During the trial, participants will undergo regular assessments including scans and lab tests to monitor tumor response and safety. The study will track side effects, dose changes, and overall treatment effects over several years, with some evaluations extending up to five years after treatment. Researchers will measure outcomes such as tumor response rate, duration of response, disease control, progression-free survival, and overall survival. Safety monitoring includes checking for adverse events and laboratory abnormalities throughout the study period.

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors