OVCA-1

• Research type

  Research Study

• Full 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)

• IRAS ID

  1013533

• Contact name

  Gertrud Rasmussen

• Contact email

  info@epitopea.com

• Sponsor organisation

  Epitopea Ltd

• Clinicaltrials.gov Identifier

  NCT07665515

• Research 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 called Cryptivax-1001 is safe when administered to patients with this specific type of ovarian cancer. The study vaccine, Cryptivax-1001, is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. This is the first time the study vaccine is administered to patients.

  The main purposes of this study are 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 consists of a pre-screening period, screening period (up to 4 weeks), a main study intervention treatment period (about 31 weeks), and a follow-up period (about 72 weeks). After the follow-up there is an extended follow-up period until the study conclusion.

  The study has two parts: Part A (Dose escalation) and an optional Part B (Dose expansion).
  Part A – Dose Escalation:
  In Part A, participants will start with a very small dose of the study vaccine. If this dose is shown to be safe, the dose will be gradually increased for participants who join later. Safety checks, including blood tests, will be done before each dose increase to help protect participants.
  Part B – Dose Expansion (optional):
  In Part B, participants will receive the safest and most effective dose identified in Part A.

  During the treatment period participants will receive the study vaccine as an injection into a muscle in the arm or thigh.

  Up to 50 people receiving different doses will join this study at several different study sites in the United Kingdom.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  26/SC/0068

• Date of REC Opinion

  17 Apr 2026

• REC opinion

  Further Information Favourable Opinion