A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers

CAN001

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

2023-02-10

2026-02-10

2028-02-10

Recruiting

Early phase I

30

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: * Prior treatment toxicities resolved to ≤ Grade 2 according to NCI CTCAE Version 4.0, unless these are considered by the investigator team to not be life threatening, e.g. alopecia, neuropathy. * Subjects receiving any other investigational agents within the preceding 4 weeks. * Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Those who have controlled brain metastases will be allowed to participate. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects ewill receive active intervention in an n=1 study design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-03-27