Actively Recruiting
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
52
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study is designed to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.
CONDITIONS
Official Title
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years who voluntarily signed informed consent
- Expected survival time of 3 months or more
- ECOG performance status 0-1
- Diagnosed with locally advanced or metastatic urothelial carcinoma or other solid tumors
- Urothelial cancer patients must have failed or be intolerant to platinum-based chemotherapy
- Prostate cancer patients must have had at least one novel hormonal therapy and taxane regimen failure or intolerance
- Clear cell renal cell carcinoma patients must have failed or be intolerant to first-line tyrosine kinase inhibitors
- Other urological malignancies must have failed standard treatment and be unsuitable for surgery or radiotherapy
- Consent to provide tumor tissue samples or meet other criteria if unable to provide
- At least one measurable lesion per RECIST v1.1
- Adequate organ function including blood counts, kidney, liver, coagulation, and cardiac function
- Toxicity from previous treatments returned to grade 1 or less, with some exceptions
- Negative pregnancy test for premenopausal women with childbearing potential and use of contraception during and 6 months after treatment
You will not qualify if you...
- Prior use of ADC drugs with topoisomerase I inhibitor toxin
- Recent chemotherapy, radiotherapy, immunotherapy, surgery, or other anti-tumor treatments within specified timeframes
- History of severe immune-related adverse events or immune-related myocarditis
- Use of immunomodulatory drugs within 14 days before study drug
- Severe cardiovascular or cerebrovascular diseases including arrhythmias, prolonged QT, recent stroke, or heart failure
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Use of systemic corticosteroids or immunosuppressants above specified doses
- Other cancers progressing or requiring treatment within 5 years, with some exceptions
- History or suspected interstitial lung disease or pulmonary inflammation
- Poorly controlled diabetes or hypertension
- Unstable thrombosis or embolism within 6 months
- Central nervous system metastases or carcinomatous meningitis, with some exceptions for stable brain metastases
- Large or symptomatic serous cavity effusions
- Allergies to study drugs or related antibodies
- Prior organ or stem cell transplantation
- Positive for HIV, active tuberculosis, or active hepatitis B or C infection
- Active infection requiring systemic treatment
- Participation in another clinical trial within 4 weeks
- History of psychotropic drug abuse or mental disorders
- Any other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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