CESTAFOUR

CESTAFOUR

CESTAFOUR is a phase I/II clinical trial where nadunolimab (CAN04) is investigated in combination with chemotherapy for treatment of three types of solid tumors: biliary tract cancer in combination with first line cisplatin and gemcitabine, colon cancer in combination with third line FOLFOX, and non-small cell lung cancer (NSCLC) in combination with second or third line docetaxel.

The primary objective in the dose escalation phase is to assess the safety of CAN04 in combination with each of the three chemotherapy regimens. Secondary objectives include effects on biomarkers and antitumor activity.

Recruitment to the CESTAFOUR study ended in October 2022 and the study will not continue to the optional expansion phase. A total of 36 patients are included in the three arms; nadunolimab in combination with cisplatin and gemcitabine (14 patients, including 8 with biliary tract cancer), FOLFOX (14 patients, including 5 with colorectal cancer) and docetaxel (8 patients, all with NSCLC). Preliminary results show acceptable safety of the combinations. A notable early observation is that two of the four NSCLC patients treated with the cisplatin and gemcitabine combination show confirmed partial response.

More mature safety and efficacy from CESTAFOUR will be presented in H2 2023.

Read more about CESTAFOUR on ClinicalTrials.gov (NCT05116891).