Actively Recruiting
Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)
Led by Sun Yat-sen University · Updated on 2026-04-30
96
Participants Needed
6
Research Sites
292 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
T
The fifth Affiliated Hospital of Guangzhou Medcial University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).
CONDITIONS
Official Title
Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed HER2-expressing locally advanced unresectable or metastatic urothelial carcinoma
- Patients in Cohort 1 have received at least one prior systemic therapy or relapsed/progressed within 12 months or could not tolerate treatment
- Patients in Cohort 2 have not received prior systemic therapy or relapsed/progressed more than 12 months after neoadjuvant/adjuvant therapy or could not tolerate treatment
- Patients in Cohort 3 have previously received platinum-based chemotherapy, immunotherapy, and Disitamab Vedotin
- At least one measurable target lesion per RECIST 1.1 criteria
- ECOG performance status 2 or less
- Adequate bone marrow, kidney (creatinine clearance > 30 mL/min), liver, and coagulation function
- Expected survival of 3 months or more
- Ability to understand study procedures and provide written informed consent
- For women of childbearing potential, negative pregnancy test within 7 days before first drug administration
- Both male and female participants must agree to use highly effective contraception until at least 180 days after study treatment ends
You will not qualify if you...
- Candidates for curative local treatment
- History of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological/psychiatric diseases
- Untreated or active spinal cord compression or central nervous system metastases unless treated and stable for at least 1 month
- Severe allergic reactions to study drugs or humanized monoclonal antibodies
- Received antitumor monoclonal antibody or other antitumor therapy within 4 weeks before study start
- Participation in other investigational drug treatments within 4 weeks before study start
- Known or suspected interstitial lung disease or moderate to severe pulmonary diseases
- Known bleeding disorders
- Recent spinal cord radiation or unresolved radiation adverse events within 4 weeks
- Immunodeficiency or recent systemic corticosteroid or immunosuppressive therapy use
- Active autoimmune diseases requiring systemic treatment within past 2 years
- History of organ or stem cell transplantation
- Known HIV infection
- Untreated active hepatitis B or C infections
- Receipt of live vaccines within 30 days before first dose
- History of other malignancies within past 3 years except certain cured cancers
- Any condition interfering with study participation or results
- Breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
2
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
The fifth Affiliated Hospital of Guangzhou Medcial University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
4
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
5
Jiangxi Cancer Center
Nanchang, Jiangxi, China, 330000
Actively Recruiting
6
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650033
Not Yet Recruiting
Research Team
Y
Yanxia Shi, Doctor
CONTACT
H
Haifeng Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here