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Prostate CancerPhase 1NCT07756593

Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer

A Phase 1 study testing Sipuleucel-T and N803 in people with Prostate Cancer and Metastatic Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metastatic Prostate Cancer
What is being tested?
Sipuleucel-T and N803
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Nov 2026to 31 Jan 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
  • Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed).
  • Currently receiving any other investigational therapeutic or imaging agents.
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  • Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Uncontrolled infection with hepatitis A.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Russell K Pachynski, M.D. contact

314-286-2341

rkpachynski@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Russell K Pachynski, M.D., 314-286-2341, rkpachynski@wustl.edu

    Russell K Pachynski, M.D.

Other trials in United States

About this study

Official title: 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

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.

Being tested
Sipuleucel-T, N803
Keywords
Prostate Cancer, Immunotherapy, Sipuleucel-T, IL-15, Metastatic Prostate Cancer, Cellular Therapy, Cytokine Therapy, Combination Trial
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sipuleucel-TBiological

    Also called Provenge, SipT

    Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.

  • N803Biological

    N-803 is a biologic that is administered subcutaneously in the abdominal area.

Study groups in NCT07756593
Study groupRoleWhat they receive
Cohort 1: Dose level 0 Starting dose: N-803 + SIP-TExperimentalPatients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 15 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
Receives: Biological: Sipuleucel-T; Biological: N803
Cohort 1: Dose level -1: N-803 + SIP-TExperimentalPatients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 10 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
Receives: Biological: Sipuleucel-T; Biological: N803
Cohort 1: Dose level -2: N-803 + SIP-TExperimentalPatients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 6 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
Receives: Biological: Sipuleucel-T; Biological: N803
Cohort 2: N-803 + SIP-TExperimentalPatients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and recommended phase 2 dose (RP2D) of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day -5 or 5 days before first SIP-T dose.
Receives: Biological: Sipuleucel-T; Biological: N803
Cohort 3: N-803 + SIP-TExperimentalPatients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and RP2D of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day 37.
Receives: Biological: Sipuleucel-T; Biological: N803

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of dose-limiting toxicities (Cohort 1 only)

    As assessed via CTCAE v6.0. Dose limiting toxicities will be evaluated according to protocol.

    Measured: 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)

    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.

    Measured: 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

    Measured: 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

    Measured: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)

Secondary outcomes (7)

  1. 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.

    Measured: Start of treatment to completion of follow-up (up to 26 months)

  2. 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.

    Measured: Start of treatment to completion of follow-up (up to 26 months)

  3. 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.

    Measured: Start of treatment to completion of follow-up (up to 26 months)

  4. 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.

    Measured: Start of treatment to date of progression or death or last follow-up (up to 26 months)

  5. Failure-free survival (FFS)

    Failure-free survival which is defined from date of treatment start to date of any progression events (radiographic progression, biochemical recurrence, or death, whichever is earlier) or date of last follow-up if experiencing no events

    Measured: Start of treatment to date of any progression events or last follow-up (up to 26 months)

  6. Time to next therapy (TTNT)

    Measured: Through completion of follow-up (up to 26 months)

  7. Overall survival (OS)

    Overall survival is defined as the date of treatment start to date of death or date of last follow-up.

    Measured: Start of treatment to death or last follow-up (up to 26 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion14 Apr 2029 (estimated)
  4. Study completion31 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07756593
Sponsor's protocol ID
26-x147
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sipuleucel-T and N803 in people with Prostate Cancer and Metastatic Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Russell K Pachynski, M.D. (314-286-2341, rkpachynski@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of dose-limiting toxicities (Cohort 1 only) (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07756593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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