Phase 1/2 of CAN04 in combination with Chemo in advanced solid tumours

• Research type

  Research Study

• Full title

  A Phase 1/2 study of CAN04, a fully humanised monoclonal antibody against IL1RAP, in combination with different chemotherapy regimens in subjects with advanced solid tumours

• IRAS ID

  1003845

• Contact name

  Ignacio Garcia-Ribas

• Contact email

  Ignacio.Garcia-Ribas@cantargia.com

• Sponsor organisation

  Cantargia AB

• Eudract number

  2021-001695-42

• Research summary

  The study consists of two phases, each with three different treatment arms consisting of the study drug nadunolimab (CAN04) in combination with a standard chemotherapy regimen.
  
  Phase 1 is the dose-finding part of the study focusing on metastatic cancer (cancers spread to regional or distant sites, such as other organs or lymph nodes), which will look for the best tolerated dose of the CAN04, meaning the dose with the least side effects in combination with chemotherapy.
  Phase 2 will be with the fixed dose of CAN04 identified during phase 1, focused on participants with Non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and Biliary tract cancer (BTC) and will investigate if CAN04 in combination with chemotherapy will be effective against cancer.
  
  Both phases will have 3 different treatment arms: CAN04 plus mFOLFOX, CAN04 plus gemcitabine/cisplatin and CAN04 plus docetaxel.
  Nadunolimab (CAN04) is an antibody-based drug designed to stick to a specific protein found on the surface of some cancer cells. This protein is named IL1RAP that stands for ‘Interleukin-1 Receptor Accessory Protein.’ This protein is important for cancer cell growth and survival and it also controls some aspects of inflammation produced by cancers. Nadunolimab (CAN04) works in a way that once attached to the target protein on the surface of cancer cells, leads to stimulating cells of the immune system to destroy the cancer cells as well as interfering with IL-1 protein leading to reduced inflammation in the area of the cancer cells.
  
  45 participants will take part in the Phase 1 study across 6 sites in Europe, and 120 participants in Phase 2 across 20 sites in Europe.
  The study has 4 periods: ‘Screening,’ ‘Treatment Period,’ ‘End of treatment’ and ‘Long-term Follow Up" for Progression free survival.
  CT/MRI, blood samples, and tumour biopsies are some of the procedures on this study, which is sponsored by Cantargia AB

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  21/EE/0212

• Date of REC Opinion

  19 Oct 2021

• REC opinion

  Further Information Favourable Opinion