Actively Recruiting
A Phase II Clinical Study of Trastuzumab Rezetecan or Combination With Adebrelimab for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma
Led by Sun Yat-sen University · Updated on 2026-04-30
96
Participants Needed
6
Research Sites
156 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
Researchers are evaluating the effectiveness and safety of Trastuzumab Rezetecan (SHR-A1811), alone or combined with Adebrelimab (SHR-1316), in treating HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). This multicenter, open-label Phase II trial focuses on three patient groups based on their prior treatments and disease progression to gain important insights on these therapies for advanced urothelial cancer. Participants receive either Trastuzumab Rezetecan alone or combined with Adebrelimab every three weeks, depending on their prior treatment history. The study includes three cohorts: those with prior systemic therapy and recent relapse, those without prior systemic therapy or late relapse, and those previously treated with platinum-based chemotherapy, immunotherapy, or Disitamab Vedotin. The trial aims to provide data on the combination therapy's potential as a new treatment option. During the study, participants will have measurable target lesions assessed according to RECIST 1.1 criteria and monitored for treatment response, progression-free survival, overall survival, disease control, response duration, and time to response over approximately 36 months. Safety is evaluated through adverse event reporting, and quality of life is assessed using specific questionnaires. Participants undergo regular laboratory tests, performance status assessments, and pregnancy testing when applicable, with follow-up continuing for up to three years.
CONDITIONS
Brief 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
- HER2 expression confirmed by pathology with IHC staining results of 1+ to 3+
- Meet criteria for one of the three cohorts based on prior treatment and relapse status
- At least one measurable target lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Adequate bone marrow, renal, hepatic, and coagulation function
- Expected survival of at least 3 months
- Understands study procedures and provides written informed consent
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Both male and female participants must agree to use highly effective contraception during and for 180 days after treatment
You will not qualify if you...
- Candidates for curative local treatment
- History of cardiovascular, liver, respiratory, renal, hematological, endocrine, neurological, or psychiatric diseases
- Known or untreated spinal cord compression or active central nervous system metastases unless stable and treated
- Known severe allergic reactions to study drug ingredients or humanized monoclonal antibodies
- Received antitumor monoclonal antibody treatment or other antitumor therapy without recovery from adverse events within 4 weeks
- Participated in other investigational drug treatments within 4 weeks
- Known or suspected interstitial lung disease or moderate to severe pulmonary diseases
- Known bleeding disorders
- Recent spinal cord radiation or unresolved radiation-related adverse events
- Diagnosed immunodeficiency or recent systemic corticosteroid or immunosuppressive therapy (except low physiological doses)
- Active autoimmune diseases requiring systemic treatment within 2 years
- History of organ or stem cell transplantation
- Known HIV infection
- Untreated active hepatitis B or C infections
- Received live vaccines within 30 days before treatment
- History of other recent malignancies except certain low-risk cancers
- Any condition that may interfere with study participation or results
- Breastfeeding women
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 36 months
Participants receive Trastuzumab Rezetecan alone or in combination with Adebrelimab every 3 weeks as part of their assigned cohort based on prior treatment history and relapse status.
Visits every 3 weeks for treatment administration and monitoring
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
H
Haifeng Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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