CANFOUR

CANFOUR

CANFOUR, the first clinical study for nadunolimab, was a combined phase I/IIa study starting in 2017. In the initial phase of CANFOUR, the aim was to study the safety of nadunolimab to determine the appropriate dose for the second part of the study, where the treatment efficacy and safety of nadunolimab in combination with chemotherapy were evaluated.

Read more about CANFOUR on ClinicalTrials.gov (NCT03267316).

Phase I: Dose escalation and safety evaluation - Completed

• Included 22 patients with pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), or colon cancer.

The results from the phase I part were published in the British Journal of Cancer in December 2021 and can be found here.

Phase IIa: Evaluation of therapeutic efficacy - Completed

• Evaluating nadunolimab in combination with chemotherapy in patients with PDAC (first line of treatment with gemcitabine/nab-paclitaxel), NSCLC (first or second line of treatment with cisplatin/gemcitabine) or non-squamous NSCLC (first or second line of treatment with carboplatin/pemetrexed).
• A total of 76 PDAC patients have been treated (36 in a primary cohort, 40 in an expansion cohort).
• Promising survival results have been observed in PDAC patients, especially patients with high expression of IL1RAP on the tumor cells.
• Nadunolimab was shown to have a protective effect on the incidence of chemotherapy-induced neuropathy.
• The results for the PDAC part were published in Clinical Cancer Research in December 2024 and can be found here.
• Interim results have been presented at scientific conferences, ASCO 2022, AACR 2023, ESMO GI 2024, ASCO Pancreatic Cancer 2023, ASCO 2024 (link to publications and scientific presentations)
• A total of 43 NSCLC patients have been treated (33 in combination with cisplatin/gemcitabine, 10 in combination with carboplatin/pemetrexed). These patients show a longer survival than expected based on historical data, and a subgroup of patients with non-squamous histology who were previously treated with pembrolizumab have an exceptionally good response. These patients had a high level of infiltrating immune cells in tumor biopsies. The results for NSCLC from the phase II part were published in Lung Cancer in August 2025 and can be found here.
• Interim results have been presented at scientific conferences, ASCO 2022 and ASCO 2023 (link to publications and scientific presentations)