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.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval