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New mRNA vaccine aims to stop ovarian Cancer's return

NCT ID NCT07665515

Disease control Sponsor: Epitopea Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 10 times

Summary

This early-stage trial tests a new mRNA cancer vaccine called CryptiVax-1001 in 50 women with advanced ovarian cancer. The vaccine is designed to train the immune system to recognize and attack cancer cells, potentially delaying or preventing the cancer from coming back. The main goal is to check safety and side effects, but researchers will also look at how well the vaccine activates the immune system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CryptiVax-1001 (mRNA cancer vaccine)
What this could lead to
If it works, this vaccine could help delay or prevent ovarian cancer from returning after standard treatment.
What could go wrong
This is an early phase 1 trial with only 50 people, so it is too soon to know if it works. The main goal is safety, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube serous adenocarcinoma ovarian cancer ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HGS ovarian, fallopian tube or primary peritoneal cancer HGSOC Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

    NOT_YET_RECRUITING

    London, SE1 9RT, United Kingdom

  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

    RECRUITING

    Preston, PR2 9HT, United Kingdom

  • Royal Marsden NHS Foundation Trust - Institute of Cancer Research

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • St. James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre

    NOT_YET_RECRUITING

    Edinburgh, EH4 2XR, United Kingdom

  • University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary

    RECRUITING

    Leicester, LE2 7LX, United Kingdom

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