Cantargia receives regulatory approval to start CESTAFOUR clinical study with nadunolimab in combination with chemotherapy.

The company has announced approval to start the phase I/II clinical study by the regulatory authority and ethics committee in France.

“CESTAFOUR is a very important trial, designed to broaden the use of nadunolimab for patient groups with very high medical need. The regulatory approval is therefore a highly important milestone and we look forward to start treating patients,” says Göran Forsberg, CEO of Cantargia.

Broadens the clinical development

This study broadens the clinical development for nadunolimab (CAN04) to include biliary tract cancer (BTC), colorectal cancer (CRC) and late-stage non-small lung cancer (NSCLC) and will evaluate CAN04 in combination with standard of care chemotherapy, states the company. The study will be conducted at approximately 20 clinical centers in Europe and will include up to a total of 165 patients.

Cantargia’s most advanced candidate, the interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN04, is investigated in multiple clinical trials in combination with various chemotherapy regimens, primarily in NSCLC and pancreatic cancer. With the aim to broaden the clinical development of CAN04, Cantargia recently submitted a clinical trial application to start a new phase I/II clinical study, CESTAFOUR, which will evaluate CAN04 in additional forms of cancer, such as BTC, CRC and late-stage NSCLC, in combination with standard of care chemotherapy.

CESTAFOUR

In CESTAFOUR, CAN04 will be evaluated as first line therapy of advanced BTC in combination with gemcitabine and cisplatin, third line therapy of CRC in combination with FOLFOX, and second or third line therapy of NSCLC in combination with docetaxel. The selected chemotherapy combinations are supported by preclinical data, showing that CAN04 enhances antitumor activity of platinum-based chemotherapy or docetaxel.

In the initial dose escalation phase of CESTAFOUR, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of the CAN04 combinations, and to establish a recommended dose of CAN04 for the subsequent part. In the phase II part, the primary objective is to assess the antitumor efficacy and will include approximately 40 patients for each of the three indications. The phase I part of the study will be performed in France, Spain and the United Kingdom, and the first patient is estimated to be enrolled in September/October 2021.

Photo of Göran Forsberg: Håkan Sandbring