Actively Recruiting
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-11-18
90
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
CONDITIONS
Official Title
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Age 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic urothelial cancer
- Phase Ib: Failed, intolerant, or refused standard treatment; Phase II: No prior systemic antitumor therapy for advanced urothelial carcinoma
- Provide archival or fresh tumor tissue sample
- Measurable disease according to RECIST version 1.1
You will not qualify if you...
- Untreated, uncontrollable, or active central nervous system metastases
- Prior treatment with TOPO1-based antibody-drug conjugates
- Anti-cancer treatment within 4 weeks before first study dose
- Radiotherapy within 14 days, or chest radiotherapy over 30 Gy within 6 months before first study dose
- Ongoing significant toxicity from prior treatment not resolved to Grade 1 or less
- Systemic immunosuppressant treatment within 14 days before first study dose
- Known or suspected interstitial pneumonitis
- For Phase Ib: History of Grade 3 or higher immune-related adverse events from prior immune checkpoint inhibitors
- Active, known, or suspected autoimmune diseases
- Moderate or severe ascites with symptoms, or uncontrolled moderate or higher pleural or pericardial effusions
- Uncontrolled cardiac diseases or symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
C
Chun Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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