Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
OVACT
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)
2 other identifiers
interventional
50
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 ovarian-cancer
Started Jul 2026
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
July 29, 2026
July 1, 2026
2.7 years
June 12, 2026
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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)
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)
Through study completion, and average of up to 2 years
Secondary Outcomes (1)
To characterise the immunogenicity of Cryptivax-1001
At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
Study Arms (6)
Dose level 1
EXPERIMENTALDose level 2
EXPERIMENTALDose level 3
EXPERIMENTALDose level 4
EXPERIMENTALDose level 5
EXPERIMENTALRecommended Dose
EXPERIMENTALRecommended phase 2 dose or another safe dose, based on Dose Escalation part
Interventions
i.m injection
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epitopea Ltdlead
Study Sites (10)
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
Edinburgh, EH4 2XR, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
St. James's University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
Leicester, LE2 7LX, United Kingdom
University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
London, NW1 2PG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Royal Marsden NHS Foundation Trust - Institute of Cancer Research
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susana Banerjee, MBBS MA FRCP PhD
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2026
First Posted
June 24, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share