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.
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.
Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator.
Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment.
Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.
Prior exposure to Sipuleucel-T.
Washington University School of Medicine
Lead sponsor
Dendreon
Collaborator
ImmunityBio, Inc.
Collaborator