Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Pr… (NCT07665515) | Clinical Trial Compass
RecruitingPhase 1
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
United Kingdom50 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of CryptiVax-1001
Timeframe: Through study completion, an average of up 2 to years
2
To evaluate the safety and tolerability of CryptiVax-1001
Timeframe: From Day 1 to Day 21
3
To evaluate the safety and tolerability of CryptiVax-1001
Timeframe: Through study completion, an average of up to 2 years
4
To evaluate the safety and tolerability of CryptiVax-1001
Timeframe: Through study completion, and average of up to 2 years