RecruitingPhase 1NCT06186414

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

An Open-Label, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in Non-Muscle-Invasive Bladder Cancer

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

152 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Muscle-Invasive Bladder Cancer (NMIBC)

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug (SIM0237), alone or combined with BCG (a standard bladder cancer treatment), in people with non-muscle-invasive bladder cancer (cancer that hasn't grown into the muscle wall) that has stopped responding to BCG therapy. **You may be eligible if...** - You are 18 or older - You have non-muscle-invasive bladder cancer confirmed by biopsy - Your cancer is BCG-unresponsive — meaning it has come back or not responded after BCG treatment - Your cancer is either carcinoma in situ (CIS) or high-grade superficial bladder cancer (Ta or T1) **You may NOT be eligible if...** - Your cancer has grown into the bladder muscle or spread elsewhere - You have had a prior radical cystectomy (bladder removal) - You have serious kidney, liver, or immune system problems - You are pregnant or breastfeeding 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

DRUGSIM0237

Several dose levels of SIM0237 will be administered as a single agent for evaluation

DRUGSIM0237 and BCG

Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation

DRUGSIM0237

RD level of SIM0237 will be administered as a single agent for evaluation

DRUGSIM0237 and BCG

RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation

Locations(14)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medcial University

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06186414

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