The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To 2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

NCT Number	NCT07445308
Lead Sponsor	Shenyang Sunshine Pharmaceutical Co., LTD. Collaborators: Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Conditions	NMIBC
Enrollment	120 participants
Start Date	2026-03-12
Primary Completion	2028-11-21 (estimated)
Study Completion	2029-12-21 (estimated)
Updated on ClinicalTrials.gov	2026-03-03