A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
Washington University School of Medicine
Summary
This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed prostate adenocarcinoma. * Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral). * Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng/dL. * Eligible for standard of care Sipuleucel-T. * Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy. * At least 18 years of…
Interventions
- BiologicalSipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
- BiologicalN803
N-803 is a biologic that is administered subcutaneously in the abdominal area.
Location
- Washington University School of MedicineSt Louis, Missouri