Clinical Trial

A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC

Recruiting Phase 1/2
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Record status
This record was last updated January 28, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
Summary
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316. To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-06-05; most recent amendment 2025-01-24.
Status change: Not Yet Recruiting → Recruiting 2022-11-28
Trial Details
NCT Number NCT05410730
Lead Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions High-risk NMIBC
Enrollment 150 participants
Start Date 2022-11-23
Primary Completion 2025-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-01-28