A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

Summary

This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors. Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated.

Timeline

Start

2017-09-19

Primary completion

2024-03-14

Completion

2024-03-14

Publications

• Paulus A, Zemaitis M, Cicenas S, Zvirbule Z, Sanfridson A, Millrud CR, Magnusson S, Losic N, Tersago D, Garcia-Ribas I, Thorsson L, Paz-Ares LG. Safety, efficacy, and analysis of biomarkers in patients with advanced non-small cell lung cancer treated with the anti-IL1RAP antibody nadunolimab (CAN04) in combination with platinum doublet. Lung Cancer. 2025 Aug;206:108664. doi: 10.1016/j.lungcan.2025.108664. Epub 2025 Jul 14.
• Robbrecht D, Jungels C, Sorensen MM, Spanggaard I, Eskens F, Fretland SO, Guren TK, Aftimos P, Liberg D, Svedman C, Thorsson L, Steeghs N, Awada A. First-in-human phase 1 dose-escalation study of CAN04, a first-in-class interleukin-1 receptor accessory protein (IL1RAP) antibody in patients with solid tumours. Br J Cancer. 2022 Apr;126(7):1010-1017. doi: 10.1038/s41416-021-01657-7. Epub 2021 Dec 13.

Drugs

Indications