Cantargia has announced that the development of nadunolimab (CAN04) has been broadened following the submission of an application of a phase I/II clinical trial to evaluate combination with chemotherapy in three different forms of solid tumors.

Thus, the development of CAN04 is expanded to biliary tract cancer (BTC) and colorectal cancer (CRC), and extended to new patient populations in non-small cell lung cancer (NSCLC). The study, called CESTAFOUR, will be conducted at approximately 20 clinical centres in Europe. The first patient is estimated to be enrolled in September 2021.

“Based on the intriguing synergies with chemotherapy, the potential for CAN04 could be very high and exploring new opportunities is of great strategic value. We are really pleased to reach this development milestone,” says Göran Forsberg, CEO of Cantargia.

CAN04

The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia’s most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in NSCLC. In the phase Ib trial CAPAFOUR, CAN04 is also evaluated for treatment of metastatic PDAC in combination with the first line chemotherapy option FOLFIRINOX. Additionally, CAN04 is investigated in a phase Ib trial, CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab in four different forms of solid tumors.

An open label phase I/II clinical trial

The clinical trial application for a fourth study, called CESTAFOUR, has now been submitted. This is an open label phase I/II clinical trial, which will evaluate CAN04 in combination with chemotherapy frequently used for treatment of three forms of solid tumors. This includes first line treatment of advanced BTC in combination with gemcitabine and cisplatin, CRC in combination with FOLFOX as third line therapy, and NSCLC in combination with docetaxel as second or third line therapy.

“The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used.”

The format originates from a basket-like design with selected combinations based on previous preclinical and clinical data for CAN04. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. Furthermore, broadening to a later stage patient group in NSCLC is based on previously communicated positive results in this disease. With an expected median survival of less than a year, the medical need in each of the chosen patient segments is very high.

In the initial dose escalation phase, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of CAN04, in combination with each of the three chemotherapy regimens. In the phase II part, the primary objective is to assess the antitumor efficacy. The phase II part 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 2021.

Photo of Göran Forsberg: Cantargia