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Sacituzumab Tirumotecan in Advanced/Metastatic Penile Squamous Cell Carcinoma (PERSEUS)
NCT07815197Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2027
- Primary completion
- Mar 2028
- Countries
- 1
- Sponsor
- Latin American Cooperative Oncology Group
- Conditions
- penile squamous cell carcinoma (PSCC)
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Overview
Phase 2, open-label, single-arm trial of sacituzumab tirumotecan in penile squamous cell carcinoma (PSCC), sponsored by Latin American Cooperative Oncology Group. Primary endpoint: Objective Response Rate by Investigator Assessment. Planned start Jan 2027; status: not yet recruiting.
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Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Sacituzumab Tirumotecan
Participants receive sacituzumab tirumotecan (sac-TMT; MK-2870) at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 8 cycles.
03
Who it enrols
Adult males with advanced or metastatic penile squamous cell carcinoma who have progressed on or after first-line platinum-based chemotherapy, with measurable disease, ECOG PS 0-1, and adequate organ function.
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Endpoints
Primary
Objective Response Rate by Investigator Assessment
Secondary
Objective Response Rate by Independent Central Review
Disease Control Rate
Clinical Benefit Rate
Duration of Response
Progression-Free Survival
Overall Survival
Incidence and Severity of Adverse Events
Treatment Compliance
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