Actively Recruiting
A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-07-17
402
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Age between 18 and 80 years, any gender
- Voluntary participation with signed informed consent
- ECOG performance status score of 0 or 1
- Estimated survival of at least 3 months
- Pathologically confirmed locally advanced unresectable or metastatic urothelial carcinoma
- Previously treated with both 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
- Ability to provide preserved or fresh tumor tissue
- Presence of at least one measurable lesion according to RECIST v1.1 criteria
- Good organ function
- Use of highly effective contraception for males with partners of childbearing potential and females of childbearing potential from consent until 8 months after last dose
You will not qualify if you...
- Planned to receive other anti-tumor therapies during the trial
- Use of unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization
- Systemic anti-tumor therapy within 4 weeks prior to randomization or palliative/local therapy within 2 weeks prior to investigational drug
- Prior antibody-drug conjugates containing topoisomerase I inhibitors
- More than three prior lines of systemic therapy for locally advanced or metastatic disease
- Prior treatment with more than one antibody-drug conjugate
- Major surgery within 4 weeks prior to randomization requiring surgery during the trial
- Use of systemic glucocorticoids or immunosuppressants within 14 days before investigational drug
- Unresolved adverse events from prior antineoplastic therapy above Grade 1
- Untreated or symptomatic active central nervous system metastases
- Serous effusion with symptoms or requiring drainage
- Malignancy diagnosed within 5 years except certain localized or treated cancers
- History or current evidence of uncontrolled interstitial pneumonitis or lung disease
- Severe infections requiring intravenous treatment
- Active hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- Serious thrombotic event within 6 months before randomization
- Significant bleeding within 3 months before first study drug
- Glycosylated hemoglobin (HbA1c) 8% or higher
- Severe cardiovascular or cerebrovascular diseases
- Allergic reaction to study treatment components
- Pregnancy or planning pregnancy during study
- Other serious diseases or conditions affecting safety or study completion
- Prior treatment for urothelial carcinoma with all chemotherapy agents in the control arm regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chi Zhang, M.M
CONTACT
Z
Zhaoxiang Wang, M.M
CONTACT
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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