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Trastuzumab Rezetecan + Gemcitabine in HER2+ UTUC
NCT07741448Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- Zhiquan Hu
- Conditions
- upper tract urothelial carcinoma (UTUC)
01
Overview
Phase 2, open-label, single-arm trial of trastuzumab rezetecan in upper tract urothelial carcinoma (UTUC), sponsored by Zhiquan Hu. Primary endpoint: Pathological Complete Response. Started Aug 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Trastuzumab Rezetecan plus Gemcitabine Group
Neoadjuvant Trastuzumab Rezetecan + Gemcitabine followed by surgery, and potentially adjuvant therapy for non-pCR patients.
03
Who it enrols
Patients aged 18-75 with HER2 2-3+ upper tract urothelial carcinoma (UTUC) eligible for radical nephroureterectomy, clinical stage T1N0M0 - T2-T4aN1M0, ECOG <= 2, adequate organ function. Excludes those with recent live vaccines, prior systemic therapy within 6 months, active autoimmune disease, immunodeficiency, pregnancy, active hepatitis B/C, HIV, severe infections, or other malignancies within 5 years.
04
Endpoints
Primary
Pathological Complete Response
Secondary
Treatment Related Adverse Events
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