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

Sponsor
Fudan University
Study ID
NCT07662863
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Sacituzumab Tirumotecan — DRUG
    4.0 mg/kg intravenously administered on Day 1 every 2 weeks.
  • MMAE-based ADC — DRUG
    EV (Enfortumab Vedotin): 1.25 mg/kg administered intravenously on Days 1, 8, and 15 of every 4 weeks. DV (Disitamab Vedotin): 2.0 mg/kg administered intravenously on Day 1 of every 2 weeks.
  • Sacituzumab Tirumotecan (Observational Cohort) — DRUG
    4.0 mg/kg intravenously administered on Day 1 every 2 weeks.

Study Details

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

Key Dates

First listed
Jun 23, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Patients receive sac-TMT (a Topo-I inhibitor-payload ADC) following failure of prior MMAE-based ADC therapy.
  • Active Comparator: Active Comparator
    Patients receive an alternative MMAE-based ADC regimen as sequential therapy following progression on or intolerance to prior MMAE-based ADC treatment.
  • Other: Observational
    An observational cohort for patients who discontinued prior MMAE-ADCs due to neurotoxicity.

Primary Outcome Measure

Peripheral Neuropathy Progression Rate (PNPR) [ Time Frame: From randomization up to the end of treatment (approximately 24 months). ]

Central Contacts

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