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

PHASE1RecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 23, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

December 31, 2030

Conditions
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Interventions
DRUG

SIM0237

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

DRUG

SIM0237 and BCG

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

DRUG

SIM0237

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

DRUG

SIM0237 and BCG

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

Trial Locations (14)

30012

NOT_YET_RECRUITING

First Hospital of Shanxi Medcial University, Taiyuan

100191

RECRUITING

Peking University Third Hospital, Beijing

150000

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Haerbin

200092

NOT_YET_RECRUITING

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

201321

ENROLLING_BY_INVITATION

Fudan University Shanghai Cancer Center, Shanghai

250012

NOT_YET_RECRUITING

Qilu Hospital of Shandong University, Jinan

266071

RECRUITING

The Affiliated Hospital of Qingdao University, Qingdao

300211

RECRUITING

The Second Hospital of Tianjin Medical University, Tianjin

325015

NOT_YET_RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

410031

RECRUITING

Hunan Cancer Hospital, Changsha

430060

NOT_YET_RECRUITING

Renmin Hospital of Wuhan University, Wuhan

450003

NOT_YET_RECRUITING

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

610041

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

INDUSTRY

lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY