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A phase I/II trial of arfolitixorin as a first-line treatment in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer

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Trial Profile

A phase I/II trial of arfolitixorin as a first-line treatment in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs Arfolitixorin (Primary) ; Fluorouracil (Primary) ; Folinic acid; Oxaliplatin
  • Indications Colorectal cancer
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 15 Apr 2026 According to an Isofol Medical media release, To further accelerate patient recruitment, the phase II part of the study will now be conducted in several additional European countries hence increasing the centers to 10-15.
  • 15 Apr 2026 According to an Isofol Medical media release, German regulatory authority has also granted approval to open an additional study center in addition to Charite Universitatsmedizin Berlin in the phase Ib part of the study to accelerate recruitment. Patient enrolment will thereby start shortly at one more university hospital in Germany.
  • 15 Apr 2026 The second part of the study, phase II will include a control arm folate based medicine, leucovorin, inclusion criteria was also changed to include patients with RAS wild type, patients treated with FOLFIRI (5-FU, irinotecan and folate) in combination with anti-EGFR treatment will also be eligible for inclusion, hence the protocol was amended.

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