NEW YORK – Debiopharm said on Wednesday that it has treated the first patient in its Phase I/II clinical trial of its radioligand therapy Debio 0228 for patients with CA IX-expressing solid tumors, including advanced kidney, pancreatic, and colorectal cancers.
In Part A of the first-in-human trial, dubbed GaLuCi, Debiopharm is first evaluating the safety and reliability of the gallium-labeled imaging agent Debio 0328 in detecting solid tumors that express the surface protein carbonic anhydrase IX, or CA IX. Then, in Part B, Debiopharm is assessing dose levels of the lutetium-labeled therapeutic Debio 0228 among the patients whose tumors show high uptake of the imaging agent. In a final part, Part C, the firm will further evaluate the treatment's safety and efficacy in patients with select tumor types.
The clinical trial is taking place at multiple international sites, though the first patient was treated at Peter MacCallum Cancer Center in Australia.
Lausanne, Switzerland-based Debiopharm said its Debio 0328/Debio 0228 imaging and therapeutic pair are the only peptide-based theranostics in clinical development targeting CA IX with pan-tumor potential. However, other firms including Telix Pharmaceuticals have CA IX-targeting theranostics in their pipeline for specific cancers, such as kidney cancer in Telix's case.
"The results of the GaLuCi trial are highly anticipated considering the therapeutic potential of Debio 0228 as observed in preclinical models," Debiopharm Chief Development Officer Angela Zubel said in a statement. "Using this theranostic pair could pave the way for personalized nuclear medicine, enabling administration of the lutetium-coupled radioligand only to patients who are more likely to respond to the therapy."