Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing CryptiVax-1001 for Ovarian Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT07665515 · Epitopea Ltd · enrollment listed as 50

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CryptiVax-1001. The registry lists allocation as randomized. Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer.

They plan to enroll about 50 people at 10 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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)

Interventions: CryptiVax-1001

Primary outcome (registry wording): To evaluate the safety and tolerability of CryptiVax-1001

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Women only
  • Able to comprehend and are willing to sign the ICF and willing to follow the study procedures
  • 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)
  • 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

Public study contact (from the registry)

Head of Development Operations

+4530660105

Gertrud.Rasmussen@epitopea.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

10 listed

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FAQ about this NCT record

Is NCT07665515 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07665515?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07665515?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary