Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistan… (NCT07756593) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
United States30 participantsStarted 2026-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 age.
* ECOG performance status ≤ 2
* Adequate bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1,500 K/cumm without granulocyte colony-stimulating factor support
* Platelets ≥ 100,000 K/cumm without transfusion
* Hemoglobin ≥ 10.0 g/dL
* Total bilirubin ≤ 1.5 x IULN
* AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN
* Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
* PSA ≤ 200 ng/mL.
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of dose-limiting toxicities (Cohort 1 only)
Timeframe: Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 (total time up to 44 days)
2
Recommended Phase II Dose (RP2D) (Cohort 1 only)
Timeframe: Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days)
3
Number of severe (grade 3+) adverse events measured via CTCAE v6.0
Timeframe: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
4
Number and type of adverse events measured via CTCAE v6.0
Timeframe: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)