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

14 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigd Koninkrijk
      • Cambridge, Verenigd Koninkrijk, CB2 0QQ
        • Werving
        • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
      • Edinburgh, Verenigd Koninkrijk, EH4 2XR
        • Nog niet aan het werven
        • The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
      • Glasgow, Verenigd Koninkrijk, G12 0YN
        • Werving
        • Beatson West of Scotland Cancer Centre
      • Leeds, Verenigd Koninkrijk, LS9 7TF
        • Werving
        • St. James's University Hospital
      • Leicester, Verenigd Koninkrijk, LE2 7LX
        • Werving
        • University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
      • London, Verenigd Koninkrijk, SE1 9RT
        • Nog niet aan het werven
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
      • London, Verenigd Koninkrijk, SW3 6JJ
        • Werving
        • Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
      • London, Verenigd Koninkrijk, NW1 2PG
        • Werving
        • University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
      • Preston, Verenigd Koninkrijk, PR2 9HT
        • Werving
        • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
      • Sutton, Verenigd Koninkrijk, SM2 5PT
        • Werving
        • Royal Marsden NHS Foundation Trust - Institute of Cancer Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Dosisniveau 1
Biologisch: CryptiVax-1001
i.m injection
Experimenteel: Dosisniveau 2
Biologisch: CryptiVax-1001
i.m injection
Experimenteel: Dosisniveau 3
Biologisch: CryptiVax-1001
i.m injection
Experimenteel: Dosisniveau 4
Biologisch: CryptiVax-1001
i.m injection
Experimenteel: Dosisniveau 5
Biologisch: CryptiVax-1001
i.m injection
Experimenteel: Recommended Dose
Recommended phase 2 dose or another safe dose, based on Dose Escalation part
Biologisch: CryptiVax-1001
i.m injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To evaluate the safety and tolerability of CryptiVax-1001
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To characterise the immunogenicity of Cryptivax-1001
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Epitopea Ltd

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 maart 2029

Studie voltooiing (Geschat)

1 april 2029

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OVCA-1
  • UTN U1111-1332-3427 (Andere identificatie: WHO)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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