Autologous Tumour Vaccine Trial

NCT05807035 | Recruiting Phase 1

• 1 other identifier: CAN001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

cancer; tumor; immunotherapy; vaccine; neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3 or 4 adverse effects

  Incidence of grade 3 or 4 adverse effects related to vaccine administration

  Interval from time of vaccination to 7 days post vaccination

Secondary Outcomes (3)

• Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Overall survival

  From date of randomization to date of death from any cause, assessed up to 60 months

• Response rate by RECIST version 1.1

  From date of randomization, assessed each 6 months up to 60 months

Study Arms (1)

Radvax

EXPERIMENTAL

This is a single arm study where all participants will get active Radvax autologous tumour vaccine weekly for 4 weeks and then monthly thereafter

Biological: Radvax

Interventions

Radvax BIOLOGICAL

Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant

Also known as: Autologous tumor vaccine

Radvax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed advanced solid cancers or hematological cancers (lymphomas only)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Australian Respiratory and Sleep Medicine Institute: collaborator

Study Sites (1)

ARASMI

Adelaide, South Australia, 5046, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

FANG vaccine

Study Officials

• Dimitar Sajkov, MBBS/PhD

  ARASMI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharen Pringle, GradCert

CONTACT

0437033400; office@arasmi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects ewill receive active intervention in an n=1 study design

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: February 10, 2023
• Primary Completion: February 10, 2026
• Study Completion (Estimated): February 10, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)