Actively Recruiting
A Randomized, Open-label, Controlled Phase III Study of SHR-A2102 Injection Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma Previously Treated with Platinum Chemotherapy and PD-(L)1 Inhibitors
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-07-17
402
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SHR-A2102 for injection compared to investigator-selected therapies in patients with locally advanced or metastatic urothelial carcinoma. These patients have previously received platinum-based chemotherapy and PD-(L)1 inhibitors. This Phase III clinical trial aims to better understand treatment options for this advanced cancer stage and is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. The study randomly assigns participants to receive either SHR-A2102 for injection or one of several approved therapies chosen by the investigator, including Docetaxel, Paclitaxel, Gemcitabine Hydrochloride, or Pemetrexed Disodium injections. Participants receive treatment according to the assigned group, and the trial monitors responses and safety over time. During the trial, participants will be regularly assessed for progression-free survival and overall survival up to approximately 1.5 to 2 years. Researchers will also evaluate response rates, disease control, treatment duration, serum drug concentrations, antibody formation, and adverse events. The study involves multiple evaluations including imaging and laboratory tests to monitor disease status and treatment effects throughout the participation period, which may last up to two years.
CONDITIONS
Brief Title
A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent.
- Aged 18 to 80 years, any gender.
- ECOG performance status of 0 or 1.
- Estimated survival of at least 3 months.
- Pathologically confirmed locally advanced unresectable or metastatic urothelial carcinoma.
- Previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors, including neoadjuvant or adjuvant therapy with recurrence or progression.
- Imaging-confirmed disease progression during or after the most recent treatment.
- Able to provide preserved or fresh tumor tissue.
- At least one measurable lesion per RECIST v1.1 criteria.
- Good organ function.
- Use of highly effective contraception for subjects of childbearing potential during and up to 8 months after treatment.
You will not qualify if you...
- Planning to receive other anti-tumor therapies during the trial.
- Use of unmarketed clinical trial drugs within 4 weeks before randomization.
- Systemic anti-tumor therapy within 4 weeks or palliative/local radiotherapy within 2 weeks before investigational drug use.
- Prior antibody-drug conjugates with topoisomerase I inhibitors.
- More than three lines of systemic therapy for advanced/metastatic disease.
- Prior treatment with more than one antibody-drug conjugate.
- Major surgery within 4 weeks before randomization that requires elective surgery during the trial.
- Systemic glucocorticoids or immunosuppressants within 14 days before investigational drug use.
- Unresolved adverse events from prior therapy worse than Grade 1.
- Untreated or uncontrolled active central nervous system metastases.
- Symptomatic serous effusion requiring drainage.
- Any malignancy within 5 years except certain adequately treated low-risk cancers.
- History or current uncontrolled interstitial lung disease or pneumonitis.
- Severe infections needing intravenous antibiotics or antivirals.
- Active hepatitis B or C infection.
- History of immunodeficiency or organ transplantation.
- Serious thrombotic events within 6 months before randomization.
- Significant bleeding within 3 months before study drug.
- HbA1c of 8% or higher.
- Severe cardiovascular or cerebrovascular diseases.
- Allergic reaction to study treatment components.
- Pregnant or planning pregnancy during the study.
- Other conditions endangering safety or study completion.
- Prior treatment with all chemotherapy agents included in the control regimen.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1.5 years
Participants receive either SHR-A2102 injection or investigator-selected therapy for advanced urothelial carcinoma.
Visits scheduled according to treatment and assessment plan
Duration - Up to approximately 2 years
Participants are monitored for survival, response to treatment, and safety for up to 2 years after treatment begins.
Visits as needed for safety and outcome assessments
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chi Zhang, M.M
Z
Zhaoxiang Wang, M.M
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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