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Trial Title:
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
NCT ID:
NCT06108492
Condition:
High-risk Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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 high-risk non-muscle invasive bladder cancer.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-2005
Description:
In dose Escalation: Five 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.
Arm group label:
SHR-2005
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 high-risk non-muscle invasive bladder cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must voluntarily agree to participate in the trial and sign a written
informed consent form;
2. ≥18 years of age, either sex;
3. Previous pathological biopsy was diagnosed as high-risk NMIBC ;
4. ECOG performance status of 0-1;
5. Life expectancy ≥ 2 years;
6. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions
within 2 weeks before the first administration;
2. Patients who were receiving treatment in other clinical trials or less than 4 weeks
from the end of the first administration in this study;
3. History of serious cardiovascular and cerebrovascular diseases;
4. Severe infection within 2 weeks prior to the first dose;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1
per NCI-CTCAE v5.0;
6. Oversize surgery or severe trauma within 4 weeks before the first use of research
drugs;
7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27,
CD357 antibodies.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Zhongshan Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianming Guo, Doctor
Phone:
+86-13681971306
Email:
Guo.jianming@zs-hospital.sh.cn
Start date:
November 28, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06108492
