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

NCT07756593 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Sipuleucel-T

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

BIOLOGICAL

N803

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

Sponsors & Collaborators

Principal Investigators

  • Russell K Pachynski, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-04-14
Completion
2031-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07756593 on ClinicalTrials.gov