RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC

Summary

This is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP). Six patients were enrolled in this study. Each patient received RC48 injection \[2.0 mg/kg, Q2W, iv\] and Toripalimab injection \[3mg/kg, Q2W, iv\] for 1\~2 cycles, and radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time. Adverse events were graded using the National Cancer Institute (NCI) Standard for the Assessment of Common Terminology for Adverse Events (CTCAE) Version 5.0 guidelines, and the occurrence of DLT in patients was observed. If the subject does not complete the safety assessment for the tolerance observation period for non-dose tolerance reasons, a new subject will be replaced.

Timeline

Start

2023-08-01

Primary completion

2023-12-13

Completion

2024-02-13

Publications

• Zhang L, Jin D, Zang J, Qian L, Zhang T, Wu Y, Ding Y, Xie F, Tang H, Xia J, Cao D, Zhang R, Zhuang G, Chen H. Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study. Neoplasia. 2025 Oct;68:101216. doi: 10.1016/j.neo.2025.101216. Epub 2025 Aug 6.

Drugs

Indications