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 phase Ib/II clinical study to evaluate the efficacy and safety of an optimized dosing regimen for its drug candidate arfolitixorin in patients with metastatic colorectal cancer. The study is initially being conducted at the leading academic hospital Charité – Universitätsmedizin Berlin, with expansion to additional sites across Europe and Japan planned for 2026.
The aim of the study is to evaluate the efficacy and safety of arfolitixorin in an optimized dosing regimen, combined with 5-FU-based chemotherapy as a first-line treatment for patients with metastatic colorectal cancer.
The study is conducted in two steps
The study is designed to be conducted in two phases. The first part, phase Ib, evaluates the safety of escalating doses of arfolitixorin in patients with RAS-mutated metastatic colorectal cancer – a particularly difficult-to-treat patient group. The maximum tolerated dose and one of the lower doses will then be further evaluated in the subsequent phase II part of the study, with a continued focus on safety and efficacy. Isofol is planning to expand the phase II study by adding a control arm in which patients receive the current standard treatment in combination with leucovorin, enabling a direct comparison of efficacy and safety with arfolitixorin. The phase II study will also include patients without RAS mutations, broadening the patient population and strengthening generalizability. The study is initially being conducted at Charité, with additional European hospitals to be added in the phase II part.
Overview and study process
Study expansion to Japan
In late 2024, Isofol’s Japanese partner Solasia decided to fund a parallel study in Japan with an identical design to the European study. The aim is to enroll Japanese patients in 2026, in parallel with the start of phase II in Europe. Data from the Japanese study will be integrated into the global study program. The expansion will increase the total number of study participants and improve diversity within the patient population, creating a solid foundation for regulatory processes in Japan and other geographic markets.
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.
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