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)

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Urothelial Carcinoma
• Intervention / Treatment: Drug: SHR-A2102 and Adebrelimab; Drug: Gemcitabine and cisplatin / carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 462
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chun Yang; Phone Number: + 86 15001953916; Email: chun.yang.cy35@hengrui.Com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Principal Investigator: Jun Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be able to sign the informed consent form in writing.
2. Female or male, 18 to 80 years of age (both inclusive).
3. ECOG performance status of 0 or 1.
4. Expected survival of≥ 3 months.
5. Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
6. No prior systemic therapy for locally advanced or metastatic disease.
7. Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
8. According to RECIST v1.1, there must be at least one measurable lesion;
9. Tolerant to cisplatin or carboplatin.
10. Adequate organ functions.
11. Agree to use medically approved contraceptive measures.

Exclusion Criteria:

1. Planned to receive any other anti-tumor therapy during the study.
2. Received other investigational products or treatments not yet marketed within 4 weeks.
3. 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.
4. 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.
5. Prior treatment with immune checkpoint inhibitors.
6. Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
7. Active autoimmune disease requiring systemic treatment within 2 years.
8. Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0.
9. Uncontrolled central nervous system metastases or carcinomatous meningitis.
10. Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage.
11. Other malignancies within 5 years.
12. History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening.
13. Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control.
14. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
15. History of immunodeficiency, or history of organ transplant.
16. Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months.
17. Subjects with clinically significant hemorrhage within 3 months.
18. Glycosylated hemoglobin (HbA1c) ≥ 8%.
19. Have serious cardiovascular and cerebrovascular diseases.
20. Allergic reaction to any component of the study treatment.
21. Subjects with active pulmonary tuberculosis.
22. Have severe dry eye, active keratitis, or corneal ulcer, or other conditions.
23. Female Subjects who are pregnant or planning to become pregnant during the study.
24. Other conditions unsuitable into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1; SHR-A2102 and Adebrelimab	Drug: SHR-A2102 and Adebrelimab; SHR-A2102 and Adebrelimab injection
Experimental: Treatment group 2; SHR-A2102 and Adebrelimab	Drug: SHR-A2102 and Adebrelimab; SHR-A2102 and Adebrelimab injection
Active Comparator: Treatment group 3; Gemcitabine and cisplatin / carboplatin	Drug: Gemcitabine and cisplatin / carboplatin; Gemcitabine injection and cisplatin injection / carboplatin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival(PFS), assessed by BICR	up to 50 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case	Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case
Overall Survival(OS)	up to 50 months
Objective response rate(ORR), assessed by BICR	up to 50 months
Disease control rate(DCR), assessed by BICR	up to 50 months
Duration of response(DoR), assessed by BICR	up to 50 months
PFS, assessed by investigator	up to 50 months
ORR, assessed by investigator	up to 50 months
DCR, assessed by investigator	up to 50 months
DoR, assessed by investigator	up to 50 months
Adverse event(AE)	up to 50 months
serious adverse event(SAE)	up to 50 months

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Carboplatin; Cisplatin
• Other Study ID Numbers: SHR-A2102-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No