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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07393542
- Acronym / sponsor ID
- SHR-A2102-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: SHR-A2102 and AdebrelimabSHR-A2102 and Adebrelimab |
| Treatment group 3 | Active comparator | Drug: Gemcitabine and cisplatin / carboplatinGemcitabine and cisplatin / carboplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A2102 and AdebrelimabSHR-A2102 and Adebrelimab injection | Drug | Treatment group 1 |
| Gemcitabine and cisplatin / carboplatinGemcitabine injection and cisplatin injection / carboplatin injection | Drug | Treatment group 3 |
Primary outcome
Progression-free survival(PFS), assessed by BICR
Time frame: up to 50 months
10 secondary outcomes
Overall Survival(OS)
Time frame: up to 50 months
Objective response rate(ORR), assessed by BICR
Time frame: up to 50 months
Disease control rate(DCR), assessed by BICR
Time frame: up to 50 months
Duration of response(DoR), assessed by BICR
Time frame: up to 50 months
PFS, assessed by investigator
Time frame: up to 50 months
ORR, assessed by investigator
Time frame: up to 50 months
DCR, assessed by investigator
Time frame: up to 50 months
DoR, assessed by investigator
Time frame: up to 50 months
Adverse event(AE)
Time frame: up to 50 months
serious adverse event(SAE)
Time frame: up to 50 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Zhang (+8618456513908, chi.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS), assessed by BICR (time frame: up to 50 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.