Phase Ib/II-study

Arfolitixorin is being developed to improve established cancer treatment by adding what the body cannot produce on its own. By addressing a known treatment gap, the goal is to help more patients gain better conditions to respond to their treatment and achieve an improved prognosis.

Isofol is conducting a clinical phase Ib/II study evaluating the efficacy and safety of a new dosing regimen of the drug candidate arfolitixorin in patients with metastatic colorectal cancer. The study is being conducted at the leading academic hospital Charité – Universitätsmedizin Berlin, and a possible expansion to Japan is planned for 2026.

The purpose of the study is to evaluate the efficacy of the drug candidate using an optimized dosing regimen in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer. The aim is to generate efficacy and safety data for further clinical development.

The study is conducted in two steps

The first part of the study, phase Ib, evaluates escalating doses of arfolitixorin. The highest tolerated dose that does not cause severe side effects will then be compared to a lower dose and further evaluated in the subsequent phase II part of the study, which focuses on safety- and efficacy evaluation. In addition, Isofol plans  to expand the study by adding a control arm in which patients receive the current standard treatment, leucovorin, to evaluate differences in efficacy and safety. The study is initially conducted at Charité, and additional sites will be added during the second part of the study.

Overview and study process

Listen to Roger Tell, CMO

Listen to Isofol’s CMO, Roger Tell, how provides an update on the ongoing clinical phase Ib/II study. The purpose of the study is to evaluate the efficacy of the drug candidate using an optimized dosing regimen in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer. 

Watch the video

Study expansion to Japan

Isofol’s partner Solasia Pharma K.K. will actively participate in the clinical development with the goal of including patients in Japan by 2026. Isofol and Solasia will jointly prepare for a Japanese study in parallel with the ongoing study at Charité.