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

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.

NCT Number	NCT07631884
Lead Sponsor	Haihua Yuan
Conditions	Solid Tumors, Neoplasms (Cancer / Tumors), Advanced Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, HER2 Expression, Biliary Tract Neoplasms +8 more
Enrollment	15 participants
Start Date	2026-06-15
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-08