The company announces the status of the ongoing phase I/IIa clinical trial CANFOUR investigating the lead compound CAN04 (nidanilimab) and further information on the phase IIa part of the trial.
So far, 15 patients have received therapy in the phase I safety part of the study, and generally the immuno-oncology antibody CAN04, targeting IL1RAP, has been well tolerated. Notably, a maximum tolerated dose or recommended phase IIa dose has not yet been established. Therefore a few more patients will be included, with results from the phase I part thereby expected in Q4 2018.
The phase IIa part is also expected to start in Q4 2018, investigating efficacy of CAN04 as both monotherapy as well as combination therapy in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer.
Results during Q4 2018
The first patient in the study started therapy in September 2017. The phase I part was originally estimated to include 15-20 patients with NSCLC, pancreatic cancer, colorectal cancer or triple negative breast cancer over a period of 12 months. The primary objective of the trial is to investigate safety and thereby establish a recommended phase II dose. At this stage, a maximum tolerated dose has not been reached, and the recommended phase II dose is not yet established. Therefore, a few more patients will be included, and results are planned to be communicated during Q4 2018. CAN04 has generally been well tolerated, the most common side effect is an infusion related reaction during the first infusion and resolving within a few hours, a side effect often observed with antibody therapy.
The Phase IIa part
The phase IIa part is planned to be initiated in Q4 2018. This part will focus on patients with NSCLC or pancreatic cancer. Besides monotherapy in these indications, combination therapies are planned to be investigated. In NSCLC, a combination will be performed with the standard therapy cisplatin/gemcitabine in patients not previously treated with chemotherapy, and with the standard therapy gemcitabine/nab-paclitaxel in patients with pancreatic cancer. It is estimated that the recruitment in the phase IIa part will take 12 months, with results available early 2020. The phase I part includes five clinical centres in four countries and the phase IIa part is planned to include approximately 20 centres in six to seven countries.
”We are very pleased with the outcome of the CANFOUR trial so far. Patient recruitment has essentially followed communicated timelines, the safety profile of CAN04 is good, and preclinical results support combination therapies. There is a need to study more patients than initially planned, leading to a more extensive phase I part. The data generated will strengthen the phase IIa part”, said Göran Forsberg, CEO of Cantargia.