Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy
Virginia Commonwealth University
Summary
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.
Description
Neuroendocrine prostate cancer (NEPC) is an aggressive variant of prostate cancer with poor outcome and limited therapeutic options. Sacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate (ADC) directed against TROP2. The purpose of this study is to investigate the efficacy and safety of Sacituzumab Tirumotecan in patients with de novo or treatment related NEPC who progress after treatment with platinum-based chemotherapy.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria 1. Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and/or additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and/or an androgen receptor pathway inhibitor (ARPI) agent. Note: Pure small cell/NEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible…
Interventions
- DrugSacituzumab Tirumotecan
Sacituzumab 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
Location
- Virginia Commonwealth UniversityRichmond, Virginia