NCT06108492

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intermediate and High-risk Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	SHR-2005	In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-12-31
• Completion: 2027-09-30
• First posted: 2023-10-31
• Last updated: 2024-12-03

Locations

1 site across 1 country: China