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NOT YET RECRUITING
NCT07445308
PHASE1/PHASE2

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.

Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-03-12

Completion Date

2029-12-21

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

SPGL008

Biological product