Advanced Urothelial CarcinomaPhase 3NCT06738251
A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma
A Phase 3 study testing SHR-A2102 for Injection, Docetaxel Injection and Paclitaxel Injection in people with Advanced Urothelial Carcinoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Urothelial Carcinoma
- What is being tested?
- SHR-A2102 for Injection, Docetaxel Injection and Paclitaxel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2025to Sep 2027
- 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
- Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.
- 18 to 80 years old (including boundary value), gender is not limited.
- ECOG performance status score of 0 or 1.
- Estimated survival ≥ 3 months.
- Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.
- Patients with locally advanced or metastatic disease who have previously received both a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor; patients who received platinum-based chemotherapy and/or a PD-(L)1 inhibitor as neoadjuvant or adjuvant therapy and experienced recurrence or progression during treatment or within 6 months after completing treatment will be considered to have received these therapies in the locally advanced/metastatic setting.
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- Imaging-confirmed disease progression during or after treatment with the most recent regimen.
- Able to provide preserved or fresh tumor tissue.
- Must be present with at least one measurable lesion according to RECIST v1.1 criteria.
- Good level of organ function.
- Male subjects whose partners are women of childbearing potential and female subjects of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 8 months after the last dose of the trial drug.
Who cannot join
- Planned to receive any other anti-tumor therapy during this trial.
- Receipt of other unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization.
- Received systemic anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to randomization, and palliative radiotherapy or local therapy within 2 weeks prior to the first use of the investigational drug.
- Prior receipt of antibody-drug conjugates containing topoisomerase I inhibitors in the composition.
- For locally advanced or metastatic disease: patients who have previously received more than three lines of systemic therapy in this setting.For neoadjuvant or adjuvant therapy: if the disease recurs or progresses during treatment or within 6 months after its completion, the patient is considered to have received first-line systemic therapy for locally advanced or metastatic disease.
- Prior treatment with more than 1 antibody-drug conjugate.
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- Major surgery other than diagnosis or biopsy within 4 weeks prior to randomization that requires elective surgery during the trial.
- Received systemic glucocorticoids (prednisone > 10 mg/day or equivalent dose) or other immunosuppressants within 14 days prior to the first use of investigational drug or randomization for immunosuppressive purposes.
- Adverse events from prior antineoplastic therapy did not recover to Grade ≤1 according to NCI-CTCAE v5.0.
- Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active central nervous system metastases. CNS metastases that have been adequately treated and whose neurological symptoms are able to return to baseline at least 4 weeks prior to randomization (with the exception of residual signs or symptoms associated with CNS treatment) may be enrolled in the study.
- Subject has a serous effusion with clinical symptoms or requiring puncture and drainage.
- Any malignancy diagnosed within 5 years prior to randomization (calculated from the date of the last anti-tumor treatment), except:Localized, low-risk prostate cancer.Papillary thyroid carcinoma, basal-cell carcinoma, or squamous-cell carcinoma of the skin that has been adequately treated and shows no evidence of disease.Other carcinomas in situ that have been adequately treated and show no evidence of disease recurrence.
- History of interstitial pneumonitis/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required systemic corticosteroid therapy.Current evidence, in the investigator's judgment, of uncontrolled interstitial pneumonitis/interstitial lung disease, non-infectious pneumonitis, or any other active pneumonitis.
- Severe infections requiring intravenous antibiotics, antivirals, or antifungals for control.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Has a history of immunodeficiency or organ transplantation.
- Any serious arterial or venous thrombotic event within 6 months before randomization.
- Those who have had significant clinically significant bleeding symptoms within 3 months before the first study drug.
- Glycosylated hemoglobin (HbA1c) ≥8%.
- Have severe cardiovascular and cerebrovascular diseases.
- Allergic reaction to any component of this study treatment.
- Female subjects who are pregnant or plan to become pregnant during the study.
- According to the judgment of the investigator, there are concomitant diseases (such as thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of the patient, or affect the patient's completion of this study.
- Prior treatment for urothelial carcinoma with all chemotherapy agents included in the control-arm regimen.
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, 010-88121122, guoj307@126.com
Jun Guo
About this study
Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A2102 for Injection Versus Investigator-selected Therapy in Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors and With or Without ADC
To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
- Conditions
- Advanced Urothelial Carcinoma
- Being tested
- SHR-A2102 for Injection, Docetaxel Injection, Paclitaxel Injection, Gemcitabine Hydrochloride for Injection, Pemetrexed Disodium for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102 for InjectionDrug
SHR-A2102 for Injection.
Docetaxel InjectionDrug
Docetaxel Injection.
Paclitaxel InjectionDrug
Paclitaxel Injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for Injection.
Pemetrexed Disodium for InjectionDrug
Pemetrexed Disodium for Injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 group | Experimental | Not described Receives: Drug: SHR-A2102 for Injection |
| Investigator-selected therapy group | Active comparator | Not described Receives: Drug: Docetaxel Injection; Drug: Paclitaxel Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Pemetrexed Disodium for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: Up to approximately 1.5 years.
Overall Survival (OS)
Measured: Up to approximately 1.5 years and 2 years.
Secondary outcomes (9)
Objective Response Rate (ORR)
Measured: Up to approximately 1.5 years and 2 years.
Disease Control Rate (DCR)
Measured: Up to approximately 1.5 years and 2 years.
Duration of Response (DoR)
Measured: Up to approximately 1.5 years and 2 years.
Serum concentrations of SHR-A2102
Measured: Up to approximately 2 years.
Serum concentrations of SHR-A2102 toxin
Measured: Up to approximately 2 years.
Anti-SHR-A2102 antibody (ADA)
Measured: Up to approximately 2 years.
Anti-SHR-A2102 neutralizing antibody (NAb)
Measured: Up to approximately 2 years.
Incidence and severity of adverse event (AE)
Measured: Up to approximately 2 years.
Incidence and severity of serious adverse event (SAE)
Measured: Up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start12 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738251
- Sponsor's protocol ID
- SHR-A2102-301
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2024
- Last updated
- 17 Jul 2025
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A2102 for Injection Versus Investigator-selected Therapy in Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors and With or Without ADC
- ClinicalTrials.gov ID
- NCT06738251
- Acronym / sponsor ID
- SHR-A2102-301
- Conditions
- Advanced Urothelial Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Dec 2024 (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.
To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 group | Experimental | Drug: SHR-A2102 for Injection |
| Investigator-selected therapy group | Active comparator | Drug: Docetaxel Injection, Drug: Paclitaxel Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Pemetrexed Disodium for Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.
- 18 to 80 years old (including boundary value), gender is not limited.
- ECOG performance status score of 0 or 1.
- Estimated survival ≥ 3 months.
- Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.
Key exclusion criteria (24 listed)
- Planned to receive any other anti-tumor therapy during this trial.
- Receipt of other unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization.
- Received systemic anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to randomization, and palliative radiotherapy or local therapy within 2 weeks prior to the first use of the investigational drug.
- Prior receipt of antibody-drug conjugates containing topoisomerase I inhibitors in the composition.
- For locally advanced or metastatic disease: patients who have previously received more than three lines of systemic therapy in this setting.For neoadjuvant or adjuvant therapy: if the disease recurs or progresses during treatment or within 6 months after its completion, the patient is considered to have received first-line systemic therapy for locally advanced or metastatic disease.
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 for InjectionSHR-A2102 for Injection. | Drug | SHR-A2102 group |
| Docetaxel InjectionDocetaxel Injection. | Drug | Investigator-selected therapy group |
| Paclitaxel InjectionPaclitaxel Injection. | Drug | Investigator-selected therapy group |
| Gemcitabine Hydrochloride for InjectionGemcitabine Hydrochloride for Injection. | Drug | Investigator-selected therapy group |
| Pemetrexed Disodium for InjectionPemetrexed Disodium for Injection. | Drug | Investigator-selected therapy group |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to approximately 1.5 years.
Overall Survival (OS)
Time frame: Up to approximately 1.5 years and 2 years.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 1.5 years and 2 years.
Disease Control Rate (DCR)
Time frame: Up to approximately 1.5 years and 2 years.
Duration of Response (DoR)
Time frame: Up to approximately 1.5 years and 2 years.
Serum concentrations of SHR-A2102
Time frame: Up to approximately 2 years.
Serum concentrations of SHR-A2102 toxin
Time frame: Up to approximately 2 years.
Anti-SHR-A2102 antibody (ADA)
Time frame: Up to approximately 2 years.
Anti-SHR-A2102 neutralizing antibody (NAb)
Time frame: Up to approximately 2 years.
Incidence and severity of adverse event (AE)
Time frame: Up to approximately 2 years.
Incidence and severity of serious adverse event (SAE)
Time frame: Up to approximately 2 years.
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 17 Jul 2025.
- 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 for Injection, Docetaxel Injection and Paclitaxel Injection in people with Advanced Urothelial Carcinoma, run by Shanghai Hengrui Pharmaceutical 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 17 Jul 2025. 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, M.M (+86-18456513908, 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) (time frame: Up to approximately 1.5 years.). The study lists 2 primary outcomes in all. 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 17 Jul 2025.