RecruitingPhase 3NCT07726992

A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

750 participants

Start Date

Aug 25, 2026

Study Type

INTERVENTIONAL

Conditions

Papillary-Only Non-muscle-invasive Bladder Cancer

Summary

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo +BCG and a drug called SHR-1501+BCG for people with papillary-only non-muscle-invasive bladder cancer. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1501+BCG

SHR-1501+BCG

DRUGPlacebo +BCG

Placebo +BCG

Locations(2)

The First Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07726992