The multi-centre international clinical trial will evaluate company’s Debio 0328 candidate

Debiopharm – a company aiming to establish future standard-of-care to cure cancer and infectious diseases – has announced that the first patient has been dosed in its first-in-human phase 1/2 trial.

The first patient received the dose and was screened at the Australia-based Peter MacCallum Cancer Centre.

The multi-centre international trial – evaluating a radioligand theranostic candidate – will be carried out in three stages. Firstly, to confirm the reliability and safety of the Debio 0328 in detecting CA IX-expressing solid tumours and, secondly, to analyse escalating doses of the therapy in patients whose tumours show high uptake of Debio 0328.

Thirdly, based on the recommended dose, there will be further assessments of safety and preliminary efficacy in selected tumour types.

Currently, Debio 0228/0328 is the only peptide-based theranostic pair targeting CA IX in clinical development, designed for patients with advanced disease such as renal, pancreatic and colorectal cancers.

Dr Ben Tran, lead genito-urinary medical oncologist at the Peter MacCallum Cancer Centre, explained: "We always have immense gratitude for our patients who participate in first time in human trials, but in this case, we are particularly thankful for our patient who agreed to be the first person in the world to have their kidney cancer imaged with Debio 0328 on the GaLuCi trial. We hope this is the beginning of the theranostics era in kidney cancer."

Angela Zubel, chief development officer at Debiopharm, reflected: "The results of the GaLuCi trial are highly anticipated considering the therapeutic potential of Debio 0228 as observed in preclinical models.”

She added: “Using this theranostic pair could pave the way for personalised nuclear medicine, enabling administration of the lutetium coupled radioligand only to patients who are more likely to respond to the therapy."

Darren Feldman, associate attending physician, genitourinary oncology service at Memorial Sloan Kettering Cancer Center, concluded: "We are excited about this first-in-human study as it is a novel approach for advanced kidney cancer patients. Precision nuclear medicine applied to CA9 could benefit advanced cancer patients who still experience a high unmet medical need."