NCT05807035

Autologous Tumour Vaccine Trial

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vaxine Pty Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Radvax	Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant

Timeline

• Start date: 2023-02-10
• Primary completion: 2026-02-10
• Completion: 2028-02-10
• First posted: 2023-04-10
• Last updated: 2025-09-17

Locations

1 site across 1 country: Australia