Phase II Study of Trastuzumab Rezetecan Treatment in Adults with HER2-Positive Advanced Solid Tumors Refractory to Standard Therapies

What this Trial Is About

Researchers are studying the use of Trastuzumab Rezetecan SHR-A1811 in patients with HER2-positive advanced solid tumors who have not responded to standard treatments or have no available standard therapies. This phase II clinical trial includes three groups of patients those with Extramammary Pagets Disease EMPD, rare solid tumors such as sarcoma or urachal cancer, and urothelial carcinoma. The purpose is to evaluate the treatments effect on tumor response and patient outcomes in these difficult-to-treat cancers. All participants receive Trastuzumab Rezetecan at a dose of 4.8 mgkg every three weeks. The study enrolls 90 patients divided equally among the three groups. Treatment continues until disease progression, withdrawal, loss to follow-up, or death. Tumor responses are checked every six weeks during treatment. After treatment ends, safety is followed for 30 days, with survival monitored every three months. Participants will undergo regular tumor imaging to assess response, and their health will be closely monitored for side effects and disease progression. Researchers will measure how many patients achieve complete or partial tumor responses. The study also tracks the time to disease progression and overall survival up to 100 months. Participants are involved for about two years, including treatment and follow-up periods, ensuring thorough safety and effectiveness monitoring.

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies