Personalized vaccine for advanced solid tumors
A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
This study is testing a personalized vaccine made from patients' own tumor proteins to see if it can help people with advanced solid cancers who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Vaxine Pty Ltd Industry-sponsored |
| Drugs / interventions | CAR-T, immunotherapy |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT05807035 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial evaluates the safety, tolerability, and response to a personalized autologous tumor vaccine (ATV) formulated with Advax adjuvant in patients with advanced solid cancers. The vaccine is created from tumor proteins extracted from patients' own tumors, combined with a non-inflammatory adjuvant. Participants will receive doses of the vaccine over several cycles, with the primary focus on monitoring adverse effects and secondary outcomes including response rates and survival metrics. The study aims to improve treatment options for patients who have not responded to existing therapies.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed advanced solid cancers who have received at least one prior therapy.
Not a fit: Patients with early-stage cancers or those who have not undergone any prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar personalized vaccine approaches, particularly in canine cancer patients and murine models, indicating potential for success in human trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects receiving any other investigational agents within the preceding 4 weeks. * Pregnant women because of the unknown risk of adverse events in the foetus secondary to treatment of the mother with ATV. * 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.
Where this trial is running
Adelaide, South Australia
- Arasmi — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Dimitar Sajkov, MBBS/PhD — Arasmi
- Study coordinator: Sharen Pringle, GradCert
- Email: office@arasmi.org
- Phone: 0437033400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.