Clinical Trial

Sacituzumab Tirumotecan vs MMAE-ADCs in Advanced Urothelial Carcinoma (FUSCC-SPARE-UC-01)

Study acronym: SPARE-UC-01
Not Yet Recruiting Phase 2
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Summary
The main goal of this clinical trial is to learn if a new targeted cancer drug called sacituzumab tirumotecan (sac-TMT) works to treat cancer while causing less nerve damage in patients with advanced urothelial carcinoma who have progressed on or could not tolerate previous treatment such as enfortumab vedotin plus pembrolizumab (EVP) or disitamab vedotin plus toripalimab (DVT). The main question it aims to answer is: Does sac-TMT lower the risk of getting severe nerve damage, as measured together by doctors, machines, and the participants? Researchers will compare sac-TMT to alternative MMAE-based ADC drugs (switching to a different MMAE-based ADC after the first one stopped working) to see if sac-TMT causes less nerve damage while still effectively treating the cancer. A small group of participants who had to stop their previous MMAE-based ADC treatment because of nerve damage will also receive sac-TMT to learn if the drug is safe for their nerves. Participants will: 1. Receive either sac-TMT or another MMAE-based ADC drug 2. Have regular physical exams by a doctor to check their nerves 3. Have machine tests to measure how well their nerves work 4. Answer survey questions about their pain, numbness, and daily activities
Trial Details
NCT Number NCT07662863
Lead Sponsor Fudan University
Conditions Bladder Cancer, Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Peripheral Neuropathy
Enrollment 75 participants
Start Date 2026-07-15
Primary Completion 2028-12-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-23