Clinical trial NCT05807035: Autologous Tumour Vaccine Trial
Official title: A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: cancer
tumor
immunotherapy
vaccine
neoplasm
Lead sponsor: Vaxine Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Australian Respiratory and Sleep Medicine Institute
First posted: 2023-04-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects ewill receive active intervention in an n=1 study design
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of grade 3 or 4 adverse effects
timeFrame: Interval from time of vaccination to 7 days post vaccination
Secondary outcomes:
measure: Progression free survival
timeFrame: 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
measure: Overall survival
timeFrame: From date of randomization to date of death from any cause, assessed up to 60 months
measure: Response rate by RECIST version 1.1
timeFrame: From date of randomization, assessed each 6 months up to 60 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: ARASMI
state: South Australia
Study officials:
affiliation: ARASMI
name: Dimitar Sajkov, MBBS/PhD
role: PRINCIPAL_INVESTIGATOR
References: