Clinical Trial

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC

Recruiting Phase 1
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Summary
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-12-29; most recent amendment 2025-01-13.
Status change: Not Yet Recruiting → Recruiting 2024-01-25
Trial Details
NCT Number NCT06186414
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Shanghai Xianxiang Medical Technology Co., Ltd.
Conditions Non-Muscle-Invasive Bladder Cancer (NMIBC)
Enrollment 152 participants
Start Date 2024-01-23
Primary Completion 2027-01 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-15