SHR-A2102 plus adebrelimab compared with standard chemotherapy for advanced urothelial cancer
Compares SHR-A2102 with adebrelimab against chemotherapy in untreated advanced urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07393542, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07393542
- Record updated
- 14 August 2026
- Original description
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.Read full original descriptionShow less
An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)
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.
Inclusion: 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≥ 3 months; Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of 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; According to RECIST v1.1, there must be at least one measurable lesion; Tolerant to cisplatin or carboplatin; Adequate organ functions; Agree to use medically approved contraceptive measures.
Exclusion: Planned to receive any other anti-tumor therapy during the study; Received other investigational products or treatments not yet marketed within 4 weeks; Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks; Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor; Prior treatment with immune checkpoint inhibitors; Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial; Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0; Active autoimmune disease requiring systemic treatment within 2 years; Other malignancies within 5 years; History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening; Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control; Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; History of immunodeficiency, or history of organ transplant; Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months; Subjects with clinically significant hemorrhage within 3 months; Have serious cardiovascular and cerebrovascular diseases; Allergic reaction to any component of the study treatment; Subjects with active pulmonary tuberculosis; History of severe dry eye, active keratitis, or corneal ulcer, or other conditions; Other conditions unsuitable into the study; Glycosylated hemoglobin (HbA1c) ≥ 8%; Uncontrolled central nervous system metastases or carcinomatous meningitis; Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage; Female Subjects who are pregnant or planning to become pregnant during the study.