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RecruitingNCT07665515OVACTUpdated Aug 17, 2026

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

A Phase 1 interventional study of CryptiVax-1001 in Ovarian Cancer, HGSOC and HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer, sponsored by Epitopea Ltd. Recruiting at 10 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Epitopea Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Ovarian Cancer
  • HGSOC
  • HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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Keywords

  • ovarian cancer
  • Maintenance
  • FIGO stage III-IV
  • HRP
  • BRCAwt
  • mRNA vaccine
  • CryptiVax-1001
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

This is the only study on the registry with Epitopea Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Dose level 1

    Biological: CryptiVax-1001

  • Experimental
    Dose level 2

    Biological: CryptiVax-1001

  • Experimental
    Dose level 3

    Biological: CryptiVax-1001

  • Experimental
    Dose level 4

    Biological: CryptiVax-1001

  • Experimental
    Dose level 5

    Biological: CryptiVax-1001

  • Experimental
    Recommended Dose

    Recommended phase 2 dose or another safe dose, based on Dose Escalation part

    Biological: CryptiVax-1001

Interventions

  • BiologicalCryptiVax-1001

    i.m injection

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerability of CryptiVax-1001

    Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events

    Time frame: Through study completion, an average of up 2 to years

  2. To evaluate the safety and tolerability of CryptiVax-1001

    Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period

    Time frame: From Day 1 to Day 21

  3. To evaluate the safety and tolerability of CryptiVax-1001

    Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)

    Time frame: Through study completion, an average of up to 2 years

  4. To evaluate the safety and tolerability of CryptiVax-1001

    Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)

    Time frame: Through study completion, and average of up to 2 years

Secondary outcomes

  1. To characterise the immunogenicity of Cryptivax-1001

    Detection and quantification of antigen-specific T cells in peripheral blood at predefined timepoints

    Time frame: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years

07

Study locations

8 of 10 sites recruiting
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
    Cambridge, CB2 0QQ, United Kingdom
    Recruiting
  • The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
    Edinburgh, EH4 2XR, United Kingdom
    Not yet recruiting
  • Beatson West of Scotland Cancer Centre
    Glasgow, G12 0YN, United Kingdom
    Recruiting
  • St. James's University Hospital
    Leeds, LS9 7TF, United Kingdom
    Recruiting
  • University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
    Leicester, LE2 7LX, United Kingdom
    Recruiting
  • University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
    London, NW1 2PG, United Kingdom
    Recruiting
  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
    London, SE1 9RT, United Kingdom
    Not yet recruiting
  • Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
    London, SW3 6JJ, United Kingdom
    Recruiting
  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
    Preston, PR2 9HT, United Kingdom
    Recruiting
  • Royal Marsden NHS Foundation Trust - Institute of Cancer Research
    Sutton, SM2 5PT, United Kingdom
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07665515
Lead sponsor
Epitopea Ltd
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Aug 17, 2026

Study contacts

Head of Development Operations
Contact
Gertrud.Rasmussen@epitopea.com
+4530660105
Head of Oncology Development
Contact
Siri.Torhaug@Epitopea.com
+4795113393
Susana Banerjee, MBBS MA FRCP PhD
principal investigator · Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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