A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

Exclusion Criteria

• •1. Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
• •2. Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.)
• •3. Confirmation of progressive disease within 6 months after completion of prior adjuvant anti-cancer treatment.
• •4. Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment.
• •5. Prior treatment with arfolitixorin.
• •6. Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC.
• •7. Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency.
• •8. Known or suspected central nervous system (CNS) metastases.
• •9. Unresolved bowel obstruction, uncontrolled Crohn's disease, or ulcerative colitis.
• •10. History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment.
• •11. Current CTCAE ≥ grade 3 diarrhea.
• •12. Current chronic infection or uncontrolled serious illness causing immunodeficiency.
• •13. Known or suspected hypersensitivity or intolerance to arfolitixorin, LV, 5-FU, oxaliplatin, or bevacizumab.
• •14. Breastfeeding patients.
• •15. Patient who received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug, prior to randomization.
• •16. Patient with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• •17. Ongoing drug or alcohol abuse, as deemed by the Investigator.
• •18. Any condition that, in the opinion of the Investigator, could compromise the patient's safety or adherence to the study protocol.
• •19. Involvement, or related to people involved in the planning or conduct of the study (applies to both Isofol Medical AB (publ) staff and staff at the study site)
• •20. Surgery (excluding previous diagnostic biopsy) in the 28-day period before randomization