Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
6 de agosto de 2026 actualizado por: Washington University School of Medicine
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Russell K Pachynski, M.D.
- Número de teléfono: 314-286-2341
- Correo electrónico: rkpachynski@wustl.edu
Ubicaciones de estudio
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Sub-Investigador:
- Jingqin Rosy Luo, Ph.D.
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Contacto:
- Russell K Pachynski, M.D.
- Número de teléfono: 314-286-2341
- Correo electrónico: rkpachynski@wustl.edu
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Investigador principal:
- Russell K Pachynski, M.D.
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Sub-Investigador:
- Peter Oppelt, M.D.
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Sub-Investigador:
- Eric Knoche, M.D.
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Sub-Investigador:
- Melissa Reimers, M.D.
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Sub-Investigador:
- Jade Tao, Ph.D.
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Sub-Investigador:
- Mark Sundermeyer, M.D.
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Investigador principal:
- Daniel Thorek, Ph.D.
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Sub-Investigador:
- John Visconti, D.O.
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Sub-Investigador:
- Wilbur Song, M.D.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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, 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.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort 1: Dose level 0 Starting dose: N-803 + SIP-T
Patients 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Otros nombres:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimental: Cohort 1: Dose level -1: N-803 + SIP-T
Patients 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Otros nombres:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimental: Cohort 1: Dose level -2: N-803 + SIP-T
Patients 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Otros nombres:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimental: Cohort 2: N-803 + SIP-T
Patients 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Otros nombres:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
|
Experimental: Cohort 3: N-803 + SIP-T
Patients 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.
|
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
Otros nombres:
N-803 is a biologic that is administered subcutaneously in the abdominal area.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of dose-limiting toxicities (Cohort 1 only)
Periodo de tiempo: 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)
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As assessed via CTCAE v6.0.
Dose limiting toxicities will be evaluated according to protocol.
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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)
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Recommended Phase II Dose (RP2D) (Cohort 1 only)
Periodo de tiempo: 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)
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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.
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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)
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Number of severe (grade 3+) adverse events measured via CTCAE v6.0
Periodo de tiempo: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Number and type of adverse events measured via CTCAE v6.0
Periodo de tiempo: Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PSA30 Response
Periodo de tiempo: Start of treatment to completion of follow-up (up to 26 months)
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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.
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Start of treatment to completion of follow-up (up to 26 months)
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PSA50 Response
Periodo de tiempo: Start of treatment to completion of follow-up (up to 26 months)
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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.
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Start of treatment to completion of follow-up (up to 26 months)
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PSA90 Response
Periodo de tiempo: Start of treatment to completion of follow-up (up to 26 months)
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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.
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Start of treatment to completion of follow-up (up to 26 months)
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Radiographic progression-free survival (PFS)
Periodo de tiempo: Start of treatment to date of progression or death or last follow-up (up to 26 months)
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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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Start of treatment to date of progression or death or last follow-up (up to 26 months)
|
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Failure-free survival (FFS)
Periodo de tiempo: Start of treatment to date of any progression events or last follow-up (up to 26 months)
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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
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Start of treatment to date of any progression events or last follow-up (up to 26 months)
|
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Time to next therapy (TTNT)
Periodo de tiempo: Through completion of follow-up (up to 26 months)
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Through completion of follow-up (up to 26 months)
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Overall survival (OS)
Periodo de tiempo: Start of treatment to death or last follow-up (up to 26 months)
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Overall survival is defined as the date of treatment start to date of death or date of last follow-up.
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Start of treatment to death or last follow-up (up to 26 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Russell K Pachynski, M.D., Washington University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de noviembre de 2026
Finalización primaria (Estimado)
14 de abril de 2029
Finalización del estudio (Estimado)
31 de enero de 2031
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-x147
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.
Marco de tiempo para compartir IPD
Data will be made available beginning 9 months and ending 36 months following publication.
Criterios de acceso compartido de IPD
Investigators who have approval to use the data by an independent review committee.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .