Actively Recruiting
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-01-15
152
Participants Needed
14
Research Sites
357 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
S
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Adults aged 18 years or older, any gender.
- Histologically confirmed BCG-unresponsive carcinoma in situ, high-grade Ta or T1 disease of bladder with predominant urothelial carcinoma.
- For dose escalation: BCG-unresponsive high-risk NMIBC.
- For dose expansion: Cohorts 1 and 3 include BCG-unresponsive CIS (with or without Ta or T1); Cohorts 2 and 4 include BCG-unresponsive high-risk Ta or T1 disease.
- No resectable disease after transurethral resection; residual carcinoma in situ is allowed.
- Patients with T1 tumors must have repeat resection and pathology confirming absence of invasive tumor.
- Not suitable for or unwilling to undergo radical cystectomy.
- ECOG performance status 0, 1, or 2.
- Life expectancy of at least 2 years.
- Adequate blood and organ function.
- Women of childbearing potential must have negative pregnancy test and agree to use contraception; male subjects agree to contraception.
- Available tumor tissue for biomarker analysis.
You will not qualify if you...
- Received TURBT, other bladder surgeries, pelvic radiotherapy, or interventional therapy within 2 weeks before first dose.
- Prior treatments with IL-15, IL-2, immune checkpoint inhibitors, ADCs, chemotherapies, oncolytic viruses, BCG, or other anti-tumor therapies unless disease progression confirmed and beyond 4 weeks before first dose.
- Participation in another investigational drug or device study.
- Not recovered from adverse events caused by previous anti-tumor treatments.
- History or evidence of muscle-invasive, locally advanced, metastatic bladder cancer or upper urinary tract and prostatic urethral tumors.
- Other malignancies within 5 years before first dose.
- Active infection or urinary tract infection requiring intravenous treatment within 2 weeks before first dose.
- Significant cardiovascular disease within 6 months before first dose.
- Known HIV/AIDS infection.
- Active or chronic hepatitis B or C infection.
- Active autoimmune diseases.
- Concurrent use of other anticancer therapy or chronic immunosuppressive corticosteroids.
- History of pneumonitis, interstitial lung disease, or severe obstructive pulmonary disease requiring steroids.
- Known allergy or intolerance to study drugs or BCG (for combination therapy).
- Prior discontinuation of BCG due to adverse events like toxemia or systemic infection.
- History of allogeneic organ transplantation or graft-versus-host disease.
- Live vaccines within 4 weeks before first dose.
- Mental illness or substance abuse interfering with study compliance.
- Pregnancy or lactation, or plans for pregnancy during study.
- Other conditions deemed inappropriate by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China, 150000
Not Yet Recruiting
4
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
5
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Not Yet Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
7
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
8
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266071
Actively Recruiting
9
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Not Yet Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Enrolling by Invitation
11
First Hospital of Shanxi Medcial University
Taiyuan, Shanxi, China, 30012
Not Yet Recruiting
12
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
13
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
Research Team
T
Tammy Wu, Ph.D
CONTACT
W
Wei Xiong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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