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

NCT07393542 | Recruiting Phase 3

• 1 other identifier: SHR-A2102-302
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS), assessed by BICR

  up to 50 months

Secondary Outcomes (11)

• 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

Study Arms (3)

Treatment group 1

EXPERIMENTAL

SHR-A2102 and Adebrelimab

Drug: SHR-A2102 and Adebrelimab

Treatment group 2

EXPERIMENTAL

SHR-A2102 and Adebrelimab

Drug: SHR-A2102 and Adebrelimab

Treatment group 3

ACTIVE COMPARATOR

Gemcitabine and cisplatin / carboplatin

Drug: Gemcitabine and cisplatin / carboplatin

Interventions

SHR-A2102 and Adebrelimab DRUG

SHR-A2102 and Adebrelimab injection

Treatment group 1; Treatment group 2

Gemcitabine and cisplatin / carboplatin DRUG

Gemcitabine injection and cisplatin injection / carboplatin injection

Treatment group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Gemcitabine; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Chun Yang

CONTACT

+ 86 15001953916; chun.yang.cy35@hengrui.Com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2025-08

Locations

CN (1)