Actively Recruiting
A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-03
462
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
CONDITIONS
Official Title
A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able to sign the informed consent form in writing.
- Female or male, 18 to 80 years of age (both inclusive).
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
- Histologically confirmed urothelial carcinoma with locally advanced unresectable or metastatic disease.
- No prior systemic therapy for locally advanced or metastatic disease.
- Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
- At least one measurable lesion according to RECIST v1.1.
- Tolerant to cisplatin or carboplatin.
- Adequate organ functions.
- Agree to use medically approved contraceptive measures.
You will not qualify if you...
- Planned to receive any other anti-tumor therapy during the study.
- Received other investigational products or treatments not yet marketed within 4 weeks.
- Received systemic anti-tumor treatment within 4 weeks; prior anti-tumor Chinese patent medicine within 2 weeks; palliative radiotherapy or local therapy within 2 weeks.
- Previously received therapy with an antibody-drug conjugate targeting Nectin-4 or containing irinotecan derivatives.
- Prior treatment with immune checkpoint inhibitors.
- Major surgery other than diagnostic or biopsy within 4 weeks, or requiring elective surgery during the trial.
- Active autoimmune disease needing systemic treatment within 2 years.
- Unresolved adverse events from previous anti-tumor treatments.
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
- Clinical symptoms or serous cavity effusion requiring puncture drainage.
- Other malignancies within 5 years.
- History of significant pulmonary disease or abnormal chest imaging.
- Serious infections requiring intravenous antibiotics, antivirals, or antifungals.
- Active hepatitis B or C infection.
- History of immunodeficiency or organ transplant.
- Arteriovenous thrombosis or cardiovascular/cerebrovascular events within 6 months.
- Clinically significant hemorrhage within 3 months.
- Glycosylated hemoglobin (HbA1c) 8% or higher.
- Serious cardiovascular or cerebrovascular diseases.
- Allergic reaction to any study treatment component.
- Active pulmonary tuberculosis.
- Severe dry eye, active keratitis, corneal ulcer, or related conditions.
- Female subjects who are pregnant or planning pregnancy during the study.
- Other conditions deemed unsuitable for the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chun Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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