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.
Sequential
Sipuleucel-T
Biological/VaccineSipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
N803
Biological/VaccineN-803 is a biologic that is administered subcutaneously in the abdominal area.
Frequency of dose-limiting toxicities (Cohort 1 only)
As assessed via CTCAE v6.0. Dose limiting toxicities will be evaluated according to protocol.
Recommended Phase II Dose (RP2D) (Cohort 1 only)
RP2D is defined as the highest dose of N-803 that has an overall DLT rate of less than 33% in total of 6 patients.
Number of severe (grade 3+) adverse events measured via CTCAE v6.0
Number and type of adverse events measured via CTCAE v6.0
PSA30 Response
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 30% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
PSA50 Response
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 50% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
PSA90 Response
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 90% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
Radiographic progression-free survival (PFS)
rPFS is defined as the duration of time from start of treatment to time of radiographic progression by PCWG3 or time of death or last follow-up, the event that occurs first. Patients who have not experienced either event at the time of analysis will be censored at their last radiographic scan date. All radiographic response criteria are assessed per PCWG3 criteria.
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Washington University School of Medicine
Lead sponsor
Dendreon
Collaborator
ImmunityBio, Inc.
Collaborator
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