Health TrialsbyHealthPanel

Autologous Tumour Vaccine Trial

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVaxine Pty Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Radvax

    Biological/Vaccine

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: RadvaxExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of grade 3 or 4 adverse effects

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

Time frame
Interval from time of vaccination to 7 days post vaccination

Secondary outcomes

1

Progression free survival

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
2

Overall survival

Overall survival

Time frame
From date of randomization to date of death from any cause, assessed up to 60 months
3

Response rate by RECIST version 1.1

modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vaxine Pty Ltd

Lead sponsor

Australian Respiratory and Sleep Medicine Institute

Collaborator

Source ClinicalTrials.gov
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