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
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
Treatments tested in this trial
- Radvax
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Vaxine Pty Ltd
Lead sponsor
Australian Respiratory and Sleep Medicine Institute
Collaborator
Source ClinicalTrials.gov