A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma

August 12, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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. History of 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group 1
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival(PFS), assessed by BICR
Time Frame: up to 50 months
up to 50 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival(OS)
Time Frame: up to 50 months
up to 50 months
Objective response rate(ORR), assessed by BICR
Time Frame: up to 50 months
up to 50 months
Disease control rate(DCR), assessed by BICR
Time Frame: up to 50 months
up to 50 months
Duration of response(DoR), assessed by BICR
Time Frame: up to 50 months
up to 50 months
PFS, assessed by investigator
Time Frame: up to 50 months
up to 50 months
ORR, assessed by investigator
Time Frame: up to 50 months
up to 50 months
DCR, assessed by investigator
Time Frame: up to 50 months
up to 50 months
DoR, assessed by investigator
Time Frame: up to 50 months
up to 50 months
Adverse event(AE)
Time Frame: up to 50 months
up to 50 months
serious adverse event(SAE)
Time Frame: up to 50 months
up to 50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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