Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy
Part of paid clinical trials in Richmond, Virginia.
- Sponsor
- Virginia Commonwealth University
- Study ID
- NCT07639086
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Neuroendocrine Prostate Cancer (NEPC)
- Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sacituzumab Tirumotecan — DRUGSacituzumab tirumotecan will be administered by intravenous (IV) infusion on Days 1, 15, and 29 of each 42-day cycle until disease progression or criteria of disease progression met
Study Details
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.
Key Dates
- Start date
- Aug 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2030
- Completion
- Mar 31, 2032
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Sacituzumab TirumotecanSacituzumab tirumotecan 4mg/kg Intravenous infusion
Primary Outcome Measure
Evaluate the objective response rate (ORR) of sacituzumab tirumotecan in NEPC per Prostate Cancer Working Group (PCWG) modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) [ Time Frame: Baseline, End of treatment, up to 30 months ]
Central Contacts
- Massey IIT Research Operations804-628-6430
- Massey CTO GU Team804-628-6430
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Asit Paul, MD (PRINCIPAL_INVESTIGATOR) |
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