Ovarian CancerPhase 1OVACTNCT07665515
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study testing CryptiVax-1001 in people with Ovarian Cancer and HGSOC, run by Epitopea Ltd at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, HGSOC, HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- What is being tested?
- CryptiVax-1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Sep 2026to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United Kingdom10 sites, 10 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, CB2 0QQ
- Recruiting
The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
Edinburgh, EH4 2XR
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
- Recruiting
St. James's University Hospital
Leeds, LS9 7TF
- Recruiting
University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
Leicester, LE2 7LX
- Recruiting
University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
London, NW1 2PG
- Recruiting
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT
- Recruiting
Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London, SW3 6JJ
- Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, PR2 9HT
- Recruiting
Royal Marsden NHS Foundation Trust - Institute of Cancer Research
Sutton, SM2 5PT
About this study
Official title: 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.
Read more
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
- Being tested
- CryptiVax-1001
- Keywords
- ovarian cancer, Maintenance, FIGO stage III-IV, HRP, BRCAwt, mRNA vaccine, CryptiVax-1001
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryptiVax-1001Biological
i.m injection
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | Not described Receives: Biological: CryptiVax-1001 |
| Dose level 2 | Experimental | Not described Receives: Biological: CryptiVax-1001 |
| Dose level 3 | Experimental | Not described Receives: Biological: CryptiVax-1001 |
| Dose level 4 | Experimental | Not described Receives: Biological: CryptiVax-1001 |
| Dose level 5 | Experimental | Not described Receives: Biological: CryptiVax-1001 |
| Recommended Dose | Experimental | Recommended phase 2 dose or another safe dose, based on Dose Escalation part Receives: Biological: CryptiVax-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of up 2 to years
To evaluate the safety and tolerability of CryptiVax-1001
Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
Measured: From Day 1 to Day 21
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)
Measured: Through study completion, an average of up to 2 years
To evaluate the safety and tolerability of CryptiVax-1001
Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
Measured: 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
Measured: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation assessing up to five different dose levels. Followed by optional dose expansion phase
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epitopea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susana Banerjee, MBBS MA FRCP PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665515
- Sponsor's protocol ID
- OVCA-1
- Other IDs
- UTN U1111-1332-3427
- Acronym
- OVACT
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07665515
- Acronym / sponsor ID
- OVACT / OVCA-1
- Keywords
- ovarian cancer, Maintenance, FIGO stage III-IV, HRP, BRCAwt, mRNA vaccine, CryptiVax-1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Epitopea LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose escalation assessing up to five different dose levels. Followed by optional dose expansion phase
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Biological: CryptiVax-1001 |
| Dose level 2 | Experimental | Biological: CryptiVax-1001 |
| Dose level 3 | Experimental | Biological: CryptiVax-1001 |
| Dose level 4 | Experimental | Biological: CryptiVax-1001 |
| Dose level 5 | Experimental | Biological: CryptiVax-1001 |
| Recommended Dose | Experimental | Biological: CryptiVax-1001Recommended phase 2 dose or another safe dose, based on Dose Escalation part |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryptiVax-1001i.m injection | Biological | Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5, Recommended Dose |
Primary outcome
To evaluate the safety and tolerability of CryptiVax-1001
Time frame: 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
To evaluate the safety and tolerability of CryptiVax-1001
Time frame: From Day 1 to Day 21
Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
To evaluate the safety and tolerability of CryptiVax-1001
Time frame: 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)
To evaluate the safety and tolerability of CryptiVax-1001
Time frame: Through study completion, and average of up to 2 years
Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
1 secondary outcome
To characterise the immunogenicity of Cryptivax-1001
Time frame: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Banerjee, MBBS MA FRCP PhD principal investigator
Royal Marsden NHS Foundation Trust
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CryptiVax-1001 in people with Ovarian Cancer and HGSOC, run by Epitopea Ltd at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Development Operations (+4530660105, Gertrud.Rasmussen@epitopea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of CryptiVax-1001 (time frame: Through study completion, an average of up 2 to years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.