Therapy Areas: Oncology
Debiopharm doses first patient in its GaLuCi first-in-human, phase 1/2 study for its CA IX-targeted radiopharmaceutical program
23 March 2023 -

Debiopharm, a Switzerland-based, global biopharmaceutical company, announced on Wednesday that it has dosed its first patient in its first-in-human, phase 1/2 study, GaLuCi for its CA IX-targeted radiopharmaceutical program.

The first subject was screened and dosed at the Australia-based Peter MacCallum Cancer Centre.

This multicenter international trial, evaluating a radioligand theranostic pair will be carried out in three stages: Part A to confirm the safety and reliability of Debio 0328 in detecting CA IX-expressing solid tumours, Part B to assess escalating doses of the therapeutic agent, Debio 0228 in patients, whose tumours show high uptake of Debio 0328 and finally, based on the recommended dose from part B, Part C will further assess safety and preliminary efficacy in selected tumour types.

The company said that Debio 0228/0328 is currently, the only peptide-based theranostic pair targeting CA IX in clinical development, with pan-tumour potential, and developed first for patients with advanced cancers such as renal, pancreatic, and colorectal. It leverages a theranostic approach to identify and deliver radiation to diseased tissues, allowing the imaging-based pre-identification of patients who have the target proteins necessary to respond to the targeted radioligand.