TrivarX (ASX: TRI) has engaged specialist contract research organisation Beyond Drug Development to support the planned Phase 1 safety trial for its proprietary Stabl-Im oncology imaging technology.
The engagement will advance clinical protocol completion, supporting clinical and regulatory documentation and clinical site selection activities.
TrivarX is targeting commencement of the Phase 1 safety study during the second half of calendar year 2026 to evaluate the safety and tolerability of Stabl-Im in healthy human volunteers following oral dosing.
Stabl-Im is an MRI-based functional imaging platform being developed to visualise actively replicating tumour cells using stable isotopes without the need for radioactive tracers in order to provide earlier and more biologically meaningful insight into tumour activity, cellular proliferation, and treatment response.
The initial Phase 1 study is expected to be an open-label sequential-cohort trial that generates human safety and tolerability data ahead of later efficacy work.
Specialist CRO Support
Beyond is a boutique therapeutic product development consultancy and contract research organisation (CRO) focused on early-phase development for biotechnology and pharmaceutical companies.
The group provides strategic, regulatory, and clinical development support across innovative therapeutic and diagnostic programs.
Beyond’s team has an average of more than 20 years’ experience, including access to specialist regulatory toxicology expertise with more than 30 years of experience supporting therapeutic and imaging product development programs.
The appointment gives TrivarX external clinical development support as Stabl-Im moves from planning toward first-in-human assessment.
Key Stabl-Im Milestone
Incoming chief executive officer Dr Danielle Meyrick said the engagement marked an important development milestone for the Stabl-Im program.
“Having worked with the group previously, I know firsthand that Beyond brings highly relevant expertise across early-phase clinical development, regulatory strategy, and imaging product advancement, which positions the program strongly as we progress toward commencement of the Phase 1 safety study,” Dr Meyrick said.
The Phase 1 study is intended to support progression toward Phase 2 efficacy studies and broader clinical imaging applications.
Dr Meyrick said the human safety and tolerability data would form a key step toward broader clinical development and commercialisation initiatives, and that Stabl-Im’s use of stable isotope imaging could create a differentiated position in oncology diagnostics.
“With protocol development and broader planning activities now underway, we remain focused on progressing the study toward commencement before the end of CY2026,” she added.
