Autologous Tumour Vaccine 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

Eligibility

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.

Conditions2

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