CryptiVax-1001 Cancer Vaccine After Surgery and Chemotherapy for High-Grade Serous Ovarian Cancer

Trial details

Who runs it

Epitopea Ltd

Trial code

NCT07665515

Record updated

10 November 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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; HLA type matching Cryptivax-1001.

Exclusion: 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; Non-epithelial or low malignant potential ovarian tumours; 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; Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.

ClinicalTrials.gov NCT07665515