Actively Recruiting
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-01-28
150
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316. To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
CONDITIONS
Official Title
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status score 2 or less
- Expected survival time of at least 2 years
- Diagnosed with high-risk non-muscle invasive bladder cancer by previous pathological biopsy
- Cystoscopy within 6 weeks before first treatment shows lesion completely removed or only carcinoma in situ remains; for T1 stage lesions, postoperative pathological results must show bladder muscle tissue
- Ineligible or unwilling to undergo radical cystectomy
- Good level of organ function
- Use contraceptive measures during treatment and for 3 months after treatment; female participants of childbearing potential must have negative serum HCG within 7 days before first treatment and must not be breastfeeding
You will not qualify if you...
- Received surgery or radiotherapy for bladder lesions within 2 weeks before first treatment
- Previously received intravesical cytotoxic chemotherapy or other drugs, immune checkpoint inhibitors, or other investigational products for NMIBC without disease progression before enrollment
- Currently receiving treatment in other clinical trials or less than 4 weeks since last trial participation
- Upper urinary tract tumor detected by CTU or MRU, urethral prostate tumor detected by cystoscopy, or other malignant tumors within 5 years before first treatment
- Active tuberculosis within 1 year before first dose
- Serious infection within 4 weeks before first treatment or fever over 38.5°C during screening
- Obvious urinary tract infections or gross hematuria posing safety concerns
- Previous discontinuation of BCG treatment due to adverse reactions like toxemia or systemic infection
- Use of immunosuppressive drugs within 2 weeks before first treatment, excluding certain corticosteroids
- Active or history of interstitial lung disease
- History of significant cardiovascular disease
- History of immunodeficiency or use of immunosuppressants
- History of active autoimmune disease
- Active hepatitis B or C infection
- Known allergy or intolerance to study drugs, BCG, or excipients
- Other serious physical or mental illness or abnormal labs increasing study risk or interfering with results; any condition deemed inappropriate by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
W
Wenliang Wang
CONTACT
Z
Zhijun Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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