drugset / Trial / NCT05488353
A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma
Phase 4
Unknown
48 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital, Southern Medical University · collabSouthern Medical University, China · collabThe Third Affiliated Hospital of Southern Medical University · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a one-arm exploratory clinical study of Disitamab Vedotin for Injection combined with Penpulimab Injection designed for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients.It will confirme the efficacy and safety of Disitamab Vedotin for Injection combined with Penpulimab Injection neoadjuvant treatment for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients. Finally, it will provide new evidence-based medical evidence for neoadjuvant therapy for such patients.
Timeline
- Start
- 2022-09-01
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
Publications
- Background Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background preliminary safety and efficacy results of RC48 combined with toripalimab in patients wit local advaned or metastatic Urothelial carcinoma(NCT04264936,RC48-C014)
- Background An Open-label, Single-arm, Multicenter, Phase II Study of RC48 to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (NCT03809013,RC48-C009)
- Background Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.
- Background Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Penpulimab | Monoclonal antibody | 200 mg | Intravenous |