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Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (OVACT)

14 de agosto de 2026 actualizado por: Epitopea Ltd

A Phase I/Ib, Multi-centre, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of CryptiVax-1001, a mRNA Lipid Nanoparticle Therapeutic Cancer Vaccine, in Participants With FIGO Stage III-IV High-Grade Serous or Predominantly Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Optimal Primary/Interval Debulking Surgery and First-Line Platinum-Based Chemotherapy (OVACT Study)

Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.

The main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.

Following surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.

The main purposes of this study are therefore to:

  • assess how well the study vaccine is tolerated and identify any side effects.
  • analyse the study vaccine's capacity to activate your immune system

The study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The OVACT study is the First in Human clinical evaluation of Cryptivax-1001 in patients with advanced high-grade serous or predominantly serous ovarian, fallopian tube, or primary peritoneal cancer, following optimal debulking surgery (R0 or R1 after either IDS or PDS), and no recurrence or progression after completion of platinum-based chemotherapy. This phase I/Ib dose escalation and expansion study will assess safety, tolerability, and immunogenicity in a population where there is a high unmet need and no clearly effective maintenance therapy options. By focusing on the BRCAwt/HRP subgroup, the study addresses the majority of patients who currently lack access to biologically-matched maintenance strategies.

The study consist of 2 parts - a dose escalation part and an optional dose expansion part

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Reino Unido
      • Cambridge, Reino Unido, CB2 0QQ
        • Reclutamiento
        • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
      • Edinburgh, Reino Unido, EH4 2XR
        • Aún no reclutando
        • The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
      • Glasgow, Reino Unido, G12 0YN
        • Reclutamiento
        • Beatson West of Scotland Cancer Centre
      • Leeds, Reino Unido, LS9 7TF
        • Reclutamiento
        • St. James's University Hospital
      • Leicester, Reino Unido, LE2 7LX
        • Reclutamiento
        • University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
      • London, Reino Unido, SE1 9RT
        • Aún no reclutando
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
      • London, Reino Unido, SW3 6JJ
        • Reclutamiento
        • Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
      • London, Reino Unido, NW1 2PG
        • Reclutamiento
        • University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
      • Preston, Reino Unido, PR2 9HT
        • Reclutamiento
        • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
      • Sutton, Reino Unido, SM2 5PT
        • Reclutamiento
        • Royal Marsden NHS Foundation Trust - Institute of Cancer Research

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:

  • Able to comprehend and are willing to sign the ICF and willing to follow the study procedures
  • Female, aged 18 years of age or older at the time of informed consent.
  • Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes
  • The FIGO 2014 stage III or IV disease at initial diagnosis.
  • Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)
  • Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).
  • In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.
  • A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.
  • No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.
  • Known BRCAwt status.
  • HRP confirmed
  • No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.
  • ECOG performance status of 0 or 1.
  • Adequate haematologic and organ function
  • Negative pregnancy test for WOCBP.
  • HLA type matching Cryptivax-1001

Exclusion Criteria:

  • Non-epithelial or low malignant potential ovarian tumours
  • Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.
  • Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death
  • Active autoimmune disease requiring systemic immunosuppression
  • Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
  • History of anaphylactic reaction to mRNA-LNP therapies.
  • Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.
  • Administration of any vaccine within 30 days prior to first dosing.
  • Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.

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: Nivel de dosis 1
Biológico: CryptiVax-1001
i.m injection
Experimental: Nivel de dosis 2
Biológico: CryptiVax-1001
i.m injection
Experimental: Nivel de dosis 3
Biológico: CryptiVax-1001
i.m injection
Experimental: Nivel de dosis 4
Biológico: CryptiVax-1001
i.m injection
Experimental: Nivel de dosis 5
Biológico: CryptiVax-1001
i.m injection
Experimental: Recommended Dose
Recommended phase 2 dose or another safe dose, based on Dose Escalation part
Biológico: CryptiVax-1001
i.m injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To evaluate the safety and tolerability of CryptiVax-1001
Periodo de tiempo: Through study completion, an average of up 2 to years
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events
Through study completion, an average of up 2 to years
To evaluate the safety and tolerability of CryptiVax-1001
Periodo de tiempo: From Day 1 to Day 21
Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
From Day 1 to Day 21
To evaluate the safety and tolerability of CryptiVax-1001
Periodo de tiempo: Through study completion, an average of up to 2 years
Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)
Through study completion, an average of up to 2 years
To evaluate the safety and tolerability of CryptiVax-1001
Periodo de tiempo: Through study completion, and average of up to 2 years
Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
Through study completion, and average of up to 2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To characterise the immunogenicity of Cryptivax-1001
Periodo de tiempo: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
Detection and quantification of antigen-specific T cells in peripheral blood at predefined timepoints
At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Epitopea Ltd

Investigadores

  • Investigador principal: Susana Banerjee, MBBS MA FRCP PhD, Royal Marsden NHS Foundation Trust

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)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2029

Finalización del estudio (Estimado)

1 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OVCA-1
  • UTN U1111-1332-3427 (Otro identificador: WHO)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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