A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients included in this study must meet all of the following criteria:

‣ Age ≥ 18 years;

⁃ Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la/mUC), including bladder, ureter, renal pelvis, and urethra. HER2 expression is defined as immunohistochemical (IHC) staining results of 1+ to 3+, and must be confirmed by the pathology department of Sun Yat-sen University Cancer Center according to ASCO/CAP guidelines.

⁃ Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed/progressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2: Patients who have not received prior systemic therapy or relapsed/progressed more than 12 months after neoadjuvant/adjuvant therapy, or those who could not tolerate treatment due to AEs. Cohort 3: Patients who have previously received platinum-based chemotherapy (including cisplatin, carboplatin, etc.), immunotherapy (including PD-1, PD-L1 inhibitors), and Disitamab Vedotin ;

⁃ At least one measurable target lesion according to RECIST 1.1 criteria;

⁃ ECOG performance status ≤ 2;

⁃ Adequate bone marrow, renal (calculated creatinine clearance \> 30 mL/min using the CG formula), hepatic, and coagulation function;

⁃ Expected survival ≥ 3 months;

⁃ The patient understands the study procedures and has provided written informed consent to participate in the study;

⁃ Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required.

‣ Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study treatment.

Locations
Other Locations
China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Sun yat-sen university cancer center
RECRUITING
Guangzhou
The fifth Affiliated Hospital of Guangzhou Medcial University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Tongji Medical Collage of Huazhong University of Science & Technology
RECRUITING
Wuhan
Contact Information
Primary
Yanxia Shi, Doctor
shiyx@sysucc.org.cn
86-020-87343486
Backup
Haifeng Li, Doctor
lihf@sysucc.org.cn
86-020-87343486
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2031-07-01
Participants
Target number of participants: 96
Treatments
Experimental: Cohort 1:Adebrelimab and Trastuzumab Rezetecan in Patients with Prior Systemic Therapy
Patients with locally advanced or metastatic UC (la/mUC) who have previously received at least one systemic treatment or experienced relapse/progression within 12 months following the last treatment, or those unable to tolerate treatment due to adverse events.
Experimental: Cohort 2: Adebrelimab and Trastuzumab Rezetecan in Treatment-Naive or Relapsed Patients
Patients locally advanced or metastatic UC (la/mUC) who have not received prior systemic therapy or who have relapsed/progressed more than 12 months after receiving neoadjuvant/adjuvant therapy, or those who cannot tolerate treatment due to adverse events.
Experimental: Cohort 3: Trastuzumab Rezetecan in Patients with Prior Platinum and Immune Therapy
Patients locally advanced or metastatic UC (la/mUC) who have previously been treated with platinum-based chemotherapy (including cisplatin, carboplatin), immune checkpoint inhibitors (such as PD-1, PD-L1 inhibitors), and Disitamab Vedotin .
Related Therapeutic Areas
Sponsors
Collaborators: The fifth Affiliated Hospital of Guangzhou Medcial University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Second Affiliated Hospital of Kunming Medical University, Tongji Medical Collage of Huazhong University of Science & Technology
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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