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RECRUITING
NCT07665515
PHASE1

Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: Epitopea Ltd

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07

Completion Date

2029-04

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

CryptiVax-1001

i.m injection

Locations (10)

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, United Kingdom

The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

St. James's University Hospital

Leeds, United Kingdom

University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary

Leicester, United Kingdom

University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit

London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, United Kingdom

Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

London, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

Preston, United Kingdom

Royal Marsden NHS Foundation Trust - Institute of Cancer Research

Sutton, United Kingdom