RecruitingPhase 1NCT06108492

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)


Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

170 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests SHR-2005, a new drug placed directly into the bladder (intravesical instillation), as a treatment for bladder cancer that has not yet invaded the muscle wall (called non-muscle invasive bladder cancer, or NMIBC). This is a Phase I safety study. **You may be eligible if...** - You are 18 or older - You have been diagnosed with intermediate or high-risk non-muscle invasive bladder cancer - You have good overall physical health and organ function - You have a life expectancy of at least 2 years **You may NOT be eligible if...** - You had bladder surgery or radiation within the last 2 weeks - You had a severe infection in the last 2 weeks - You had major surgery or serious trauma in the last 4 weeks - You are currently in another clinical trial or recently ended one - You have a history of serious heart or brain vascular disease - You have previously received certain immune-stimulating antibody therapies Talk to your doctor to see if this trial is right for you.

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-2005

In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.


Locations(1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

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NCT06108492