Cantargia’s clinical trial application to study the antibody CAN04 in patients with cancer has been approved by the regulatory authorities as well as the ethics committees in Denmark and Norway.
The review is ongoing in additional countries.
The regulatory approvals by the Danish Medicines Agency, Norwegian Medicines Agency and by the ethics committees in Copenhagen and Oslo, follows the previously communicated submission of the CANFOUR phase I/IIa clinical trial application May 12, 2017. In this trial, Cantargia’s antibody CAN04, directed towards the molecular target IL1RAP, will be investigated in patients with cancer. CAN04 works through an immuno-oncology mode of action and stimulates immune cells to eradicate tumor cells as well as counteracts tumor inflammation. The indications of primary focus in this trial are non-small cell lung cancer and pancreatic cancer. The primary endpoint will be safety. Other endpoints include pharmacokinetics, efficacy and biomarkers.
From preclinical to clinical
The first part of the trial will be a dose escalation phase, investigating different dose levels of CAN04. This part is expected to take approximately 12 months. After data analysis, a second part is planned to include one monotherapy treatment arm in approximately 20 patients with non-small cell lung cancer or pancreatic cancer, as well as a combination therapy arm investigating CAN04 with standard therapy in one of these forms of cancer. The exact choice of indication and combination therapy will be decided after completion of the first part. The trial is planned to be conducted as a multicentre trial in the BeNeLux and Scandinavia.Approvals in the remaining countries are expected during the summer.Trial information will be found on www.clinicaltrials.gov.
“Cantargia is in the transition from a preclinical stage company to a clinical stage company”, Göran Forsberg, CEO of Cantargia, says. “With the regulatory approval, we have passed a milestone of major importance”.