Cantargia reported that after both FDA and IRB review, regulatory approval has been granted to start recruiting patients in a controlled phase IIb trial in metastatic pancreatic cancer investigating nadunolimab as first line combination therapy. The trial is planned to start mid-2024 with initial results 2025. The planned phase IIb trial (PANFOUR) in metastatic PDAC will investigate first line treatment of nadunolimab in combination with standard of care chemotherapy (gemcitabine/nab-paclitaxel).

Two different dose levels of nadunolimab will be investigated and the study will include a control arm with chemotherapy only. Each arm will consist of approximately 50 patients, totaling 150 patients in the trial, with a data review after approximately 60 patients. Patients will be enrolled in the US and in a number of European countries where regulatory approval is awaited.

The current plan is to start the trial during mid-2024 although the exact time point is pending ongoing financing discussions.