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

Sponsor
Sun Yat-sen University
Study ID
NCT07241793
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab (1200 mg) every 3 weeks (Q3W).
  • Trastuzumab Rezetecan — DRUG
    Trastuzumab Rezetecan (4.8 mg/kg) every 3 weeks (Q3W).

Study Details

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).

Key Dates

First listed
Nov 21, 2025
Start date
Nov 20, 2025
Status verified
Apr 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2031

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 .

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Within approximately 36 months ]

Central Contacts

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