drugset / Trial / NCT07631884

Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor

NCT07631884

Phase 2 Not yet recruiting 15 enrolled Haihua Yuan
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants. The main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg/kg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.

Timeline

Start
2026-06-15
Primary completion
2028-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Rezetecan Monoclonal antibody 4.8 mg/kg Intravenous
Subject Trastuzumab Rezetecan Monoclonal antibody 408 mg Intravenous