A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
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)
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
462 participants
Feb 12, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria24
- 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.
- Active autoimmune disease requiring systemic treatment within 2 years.
- Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0.
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
- Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage.
- 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.
- Glycosylated hemoglobin (HbA1c) ≥ 8%.
- Have serious cardiovascular and cerebrovascular diseases.
- Allergic reaction to any component of the study treatment.
- Subjects with active pulmonary tuberculosis.
- Have severe dry eye, active keratitis, or corneal ulcer, or other conditions.
- Female Subjects who are pregnant or planning to become pregnant during the study.
- Other conditions unsuitable into the study.
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Interventions
SHR-A2102 and Adebrelimab injection
Gemcitabine injection and cisplatin injection / carboplatin injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07393542