Solid TumorPhase 1NCT05807035
Autologous Tumour Vaccine Trial
A Phase 1 study testing Radvax in people with Solid Tumor, run by Vaxine Pty Ltd at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Radvax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Feb 2023to 10 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
ARASMI
Adelaide, South Australia, 5046
Sharen Pringle, 0437033400, office@arasmi.org
Dimitar Sajkov, MBBS/PhD
About this study
Official title: A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
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
Read the detailed description
Radvax is a newly developed vaccine where extracted autologous tumour proteins are combined with the non-inflammatory Advax delta inulin adjuvant. Cancer immunotherapy has had a renewed interest due to the recent success and regulatory approval of immune checkpoint inhibitors and CAR-T cells. However, only a proportion of cancer patients derive benefit from these agents and hence there is an ongoing need to improve outcomes of patients with advanced solid tumours. Radvax is a novel simplified ATV approach whereby soluble tumour antigens are extracted from tumour samples obtained at surgery or from biopsy and formulated with Advax adjuvant. This vaccine has shown efficacy in murine models of glioma and pancreatic cancer, clinical trials of canine cancer patients. Radvax is now being assessed in a Phase 1 clinical trial of advanced solid cancers. Autologous tumour vaccines (ATV) will be generated from surgically removed or biopsied fresh tumour tissue. ATV is manufactured as a tumour lysate extract which is stored frozen, and then formulated with Advax adjuvant on day of administration. Doses of ATV will be administered on days 1, 8, 15, 22 during cycle 1 and then 4 weeks thereafter until total of up to 12 cycles Primary Endpoint(s): Incidence of grade 3 or 4 adverse effects Secondary Endpoint(s): Response rates by iRECIST, progression free survival and overall survival Exploratory Endpoints: To study parameters and predictive biomarkers of cancer response
- Conditions
- Solid Tumor
- Being tested
- Radvax
- Keywords
- cancer, tumor, immunotherapy, vaccine, neoplasm
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadvaxBiological
Also called Autologous tumor vaccine
Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Radvax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 or 4 adverse effects
Incidence of grade 3 or 4 adverse effects related to vaccine administration
Measured: Interval from time of vaccination to 7 days post vaccination
Secondary outcomes (3)
Progression free survival
Progression free survival
Measured: 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
Overall survival
Measured: From date of randomization to date of death from any cause, assessed up to 60 months
Response rate by RECIST version 1.1
modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials
Measured: From date of randomization, assessed each 6 months up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start10 Feb 2023
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects ewill receive active intervention in an n=1 study design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaxine Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Australian Respiratory and Sleep Medicine Institute
- Responsible party
- Sponsor
- Investigators
- Dimitar Sajkov, MBBS/PhD, Principal investigator, ARASMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807035
- Sponsor's protocol ID
- CAN001
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT05807035
- Acronym / sponsor ID
- CAN001
- Conditions
- Solid Tumor
- Keywords
- cancer, tumor, immunotherapy, vaccine, neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vaxine Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Australian Respiratory and Sleep Medicine Institute
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Radvax is a newly developed vaccine where extracted autologous tumour proteins are combined with the non-inflammatory Advax delta inulin adjuvant. Cancer immunotherapy has had a renewed interest due to the recent success and regulatory approval of immune checkpoint inhibitors and CAR-T cells. However, only a proportion of cancer patients derive benefit from these agents and hence there is an ongoing need to improve outcomes of patients with advanced solid tumours. Radvax is a novel simplified ATV approach whereby soluble tumour antigens are extracted from tumour samples obtained at surgery or from biopsy and formulated with Advax adjuvant. This vaccine has shown efficacy in murine models of glioma and pancreatic cancer, clinical trials of canine cancer patients. Radvax is now being assessed in a Phase 1 clinical trial of advanced solid cancers. Autologous tumour vaccines (ATV) will be generated from surgically removed or biopsied fresh tumour tissue. ATV is manufactured as a tumour lysate extract which is stored frozen, and then formulated with Advax adjuvant on day of administration. Doses of ATV will be administered on days 1, 8, 15, 22 during cycle 1 and then 4 weeks thereafter until total of up to 12 cycles Primary Endpoint(s): Incidence of grade 3 or 4 adverse effects Secondary Endpoint(s): Response rates by iRECIST, progression free survival and overall survival Exploratory Endpoints: To study parameters and predictive biomarkers of cancer response
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects ewill receive active intervention in an n=1 study design
| Arm | Type | Receives |
|---|---|---|
| Radvax | Experimental | Biological: RadvaxThis is a single arm study where all participants will get active Radvax autologous tumour vaccine weekly for 4 weeks and then monthly thereafter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadvaxAlso: Autologous tumor vaccineVaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant | Biological | Radvax |
Primary outcome
Incidence of grade 3 or 4 adverse effects
Time frame: Interval from time of vaccination to 7 days post vaccination
Incidence of grade 3 or 4 adverse effects related to vaccine administration
3 secondary outcomes
Progression free survival
Time frame: 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
Time frame: From date of randomization to date of death from any cause, assessed up to 60 months
Response rate by RECIST version 1.1
Time frame: From date of randomization, assessed each 6 months up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitar Sajkov, MBBS/PhD principal investigator
ARASMI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radvax in people with Solid Tumor, run by Vaxine Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharen Pringle, GradCert (0437033400, office@arasmi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3 or 4 adverse effects (time frame: Interval from time of vaccination to 7 days post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.