Autologous Tumour Vaccine Trial

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Incidence of grade 3 or 4 adverse effects [Срок оценки: Interval from time of vaccination to 7 days post vaccination]

Вторичные конечные точки (3)

• Progression free survival [Срок оценки: 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]
• Overall survival [Срок оценки: From date of randomization to date of death from any cause, assessed up to 60 months]
• Response rate by RECIST version 1.1 [Срок оценки: From date of randomization, assessed each 6 months up to 60 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• ARASMI — Adelaide

Идентификаторы

NCT: NCT05807035 · CAN001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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