Clinical Trial

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Recruiting Phase 1
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Summary
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-25; most recent amendment 2024-11-28.
Status change: Not Yet Recruiting → Recruiting 2023-12-27
Trial Details
NCT Number NCT06108492
Lead Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Enrollment 170 participants
Start Date 2023-11-28
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-03