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

Sponsor
Epitopea Ltd
Study ID
NCT07665515
Phase
PHASE1
Status
Recruiting
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Conditions

  • HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer
  • HGSOC
  • Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CryptiVax-1001 — BIOLOGICAL
    i.m injection

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1
  • Experimental: Dose level 2
  • Experimental: Dose level 3
  • Experimental: Dose level 4
  • Experimental: Dose level 5
  • Experimental: Recommended Dose
    Recommended phase 2 dose or another safe dose, based on Dose Escalation part

Primary Outcome Measure

To evaluate the safety and tolerability of CryptiVax-1001 [ Time Frame: Through study completion, an average of up 2 to years ]

Central Contacts

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