Locally Advanced or Metastatic Urothelial CarcinomaPhase 3NCT07393542
A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 3 study testing SHR-A2102 and Adebrelimab and Gemcitabine and cisplatin / carboplatin in people with Locally Advanced or Metastatic Urothelial Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Carcinoma
- What is being tested?
- SHR-A2102 and Adebrelimab and Gemcitabine and cisplatin / carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2026to 31 Oct 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History of 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo
About this study
Official title: 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.
- Being tested
- SHR-A2102 and Adebrelimab, Gemcitabine and cisplatin / carboplatin
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102 and AdebrelimabDrug
SHR-A2102 and Adebrelimab injection
Gemcitabine and cisplatin / carboplatinDrug
Gemcitabine injection and cisplatin injection / carboplatin injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | SHR-A2102 and Adebrelimab Receives: Drug: SHR-A2102 and Adebrelimab |
| Treatment group 3 | Active comparator | Gemcitabine and cisplatin / carboplatin Receives: Drug: Gemcitabine and cisplatin / carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS), assessed by BICR
Measured: up to 50 months
Secondary outcomes (10)
Overall Survival(OS)
Measured: up to 50 months
Objective response rate(ORR), assessed by BICR
Measured: up to 50 months
Disease control rate(DCR), assessed by BICR
Measured: up to 50 months
Duration of response(DoR), assessed by BICR
Measured: up to 50 months
PFS, assessed by investigator
Measured: up to 50 months
ORR, assessed by investigator
Measured: up to 50 months
DCR, assessed by investigator
Measured: up to 50 months
DoR, assessed by investigator
Measured: up to 50 months
Adverse event(AE)
Measured: up to 50 months
serious adverse event(SAE)
Measured: up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start12 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393542
- Sponsor's protocol ID
- SHR-A2102-302
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided