NCT05807035RecruitingPhase 1
Autologous Tumour Vaccine Trial
A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Phase 1 trial to evaluate the feasibility of preparation, safety, tolerability and response to a personalised autologous tumour vaccine (ATV) formulated with Advax adjuvant when administered to patients with advanced solid cancers either as monotherapy or in combination with other standard of care agents
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- 10 Feb 2023
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Vaxine Pty Ltd
- Diseases
- Childhood cancers
- NCT number
- NCT05807035
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 10 Feb 2023 to the primary completion date, 10 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects receiving any other investigational agents within the preceding 4 weeks.
Other illness
- Any potential participant where suitable cancer tissue is not available for preparation of the vaccine
- Any condition that the Investigator deems may make a potential participant unsuitable for entry into the trial.
Other
- Pregnant women because of the unknown risk of adverse events in the foetus secondary to treatment of the mother with ATV.
Who the study is looking for
- Subjects must have histologically or cytologically confirmed advanced solid cancers or hematological cancers (lymphomas only)
- Subjects must have received at least one prior therapy for this disease, with the exception that subjects for whom no standard therapy options exist or who decline standard therapies can be considered for inclusion after discussions with the investigator team.
- Performance status ≤ 2 (ECOG performance status)
- Subjects or their parents if a child must have the ability to understand and the willingness to sign a written informed consent document.
- If no suitable cancer tissue is already available to make the vaccine, to be enrolled in the trial participants must be willing to undergo surgery and/or fresh tumour biopsy to obtain tissue to allow the preparation of the vaccine and their primary care team needs to have agreed to perform these procedures for them to obtain tumour tissue. The trial team will provide advice on appropriate tissue collection and arrange transport and processing but are not responsible for arranging such surgery or paying for its cost.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ARASMI Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.