005-study (Phase 1/2a)


Isofol has completed a Phase I/IIa study, ISO-CC-005, which evaluated the safety and efficacy of arfolitixorin in patients with mCRC. The main purpose was to establish a safe and effective dose for future studies and clinical practice. The dose definition part of the study was completed in March 2018.

After selected 120 mg of arfolitixorin/m² as a continued study dose, the study was expanded with an additional treatment group of 11 patients treated with the dosing regimen, arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab, which is now used in the enrolling AGENT study. Patient data from these 11 patients showed a positive safety profile for the treatment regimen, which was a requirement from the FDA to initiate the global phase 3 study, AGENT.

Isofol has since started two additional treatment groups to generate more safety and efficacy data. The goal was to recruit at least 40 mCRC patients in the first line treatment (initial treatment), who for at least 8 weeks receive treatment with arfolitixorin in combination with 5-FU and oxaliplatin or in combination with 5-FU and irinotecan. Patients are  evaluated for safety and efficacy by measuring side effects and tumor shrinkage.

In total, 105 patients were totally randomized in the study.

Follow the study data here >>