The first patient in the CANFOUR clinical trial has received three cycles of treatment with the antibody CAN04 and thereby, the first patient has formally completed the safety evaluation period according to the clinical protocol.
Two additional patients have received therapy with CAN04. No serious adverse events have been recorded. The ongoing clinical trial is a combined dose escalation/dose expansion phase I/IIa trial carried out in patients with non-small cell lung cancer, pancreatic cancer, colorectal cancer or triple negative breast cancer. The CAN04 antibody is targeted against IL1RAP, found in a number of cancer forms.
The first sites in the phase I/IIa clinical trial CANFOUR have been initiated and patient recruitment is ongoing. According to the protocol, patients are recruited in groups of three. Following the start of patient recruitment, all three patients in the first group has now each been given at least two infusions of CAN04.The first patient has completed three infusions and has been followed through a safety evaluation period of 21 days. No serious adverse events have been noted and once all three patients have received three infusions and have completed their 21-day safety evaluation period, the next dose group can be recruited
In the CANFOUR trial, treatment using Cantargia’s proprietary antibody CAN04, directed towards the molecular target IL1RAP, is investigated in patients with cancer. CAN04 works through a dual immuno-oncology mode of action and stimulates immune cells to eradicate tumor cells as well as counteracts tumor inflammation by blocking interleukin-1 signalling. The indications studied in this trial are non-small cell lung cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer. The relevance of targeting IL1RAP has been documented in all these diseases. The primary endpoint for the trial is safety. Other endpoints include pharmacokinetics, efficacy and biomarkers.
The first part of the trial is a dose escalation phase, investigating repeated infusions of CAN04 at different dose levels in order to identify the dose to be used in phase II. The results from this part are expected during summer 2018. After data analysis, the second part is planned to further investigate CAN04 as monotherapy treatment 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 conducted at highly regarded and well experienced sites in Denmark, Norway, Belgium and the Netherlands.Trial information can be found on www.clinicaltrials.gov.
“We are excited to have started treatment of patients in this important trial”, Göran Forsberg, CEO of Cantargia, says. “The initiation of sites and recruitment of patients follow our plan”.