The study arm is anticipated to enrol around 36 subjects across approximately 15 clinical sites. Credit: Volha_R / Shutterstock.

ITM Isotope Technologies Munich and Swiss-based Debiopharm have announced the imaging of the first subject in a new study arm (Part D) of the Phase I/II trial assessing peptide-based theranostic pair ITM-91/ITM-94 to detect and treat those with unresectable, locally advanced or metastatic solid tumours.

The five-part trial aims to evaluate the safety, tolerability, and imaging characteristics of the pair.

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Part D of the trial will assess ITM-94鈥檚 effectiveness in classifying indeterminate renal mass as either clear cell renal cell carcinoma (ccRCC) or non-cancerous.

This is compared to imaging methods such as CT/MRI and histopathology. Secondary endpoints encompass the specificity, sensitivity, and predictive value of ITM-94 PET/CT imaging.

The study arm is anticipated to enrol around 36 subjects across approximately 15 clinical sites in the US, Australia, and the EU.

Part A has already shown promising imaging capabilities of ITM-94 while Part B is currently investigating the escalating dosage of ITM-91.

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Following this, Part C will focus on the preliminary efficacy and safety of ITM-91 in various cancer types.

Last September, ITM secured the exclusive global licence for the development and commercial rights of the pair from Debiopharm.

The investigational theranostic pair, discovered by 3B Pharmaceuticals originally and currently licensed to ITM, combines the Gallium-68 (鈦垛伕Ga)-labelled PET imaging candidate, ITM-94, with Lutetium-177 (鹿鈦封伔Lu)-labelled radiotherapeutic candidate, ITM-91.

ITM chief medical officer Dr Celine Wilke said: 鈥淚TM-94 has already demonstrated potential exceptional imaging qualities, including high tumour-to-background ratios and detecting lesions not visible by CT scan with a potential favourable safety profile.

鈥淲e look forward to exploring the full potential of the theranostic pair ITM-91/ITM-94 across this trial to characterise and treat CAIX-expressing cancer cells, advancing the efficacy of targeted radiopharmaceutical therapies.鈥�

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