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A Phase 1b/2 Study of Arfolitixorin Combined With 5-fluorouracil, Oxaliplatin, and Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

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Trial Profile

A Phase 1b/2 Study of Arfolitixorin Combined With 5-fluorouracil, Oxaliplatin, and Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Aug 2025

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At a glance

  • Drugs Arfolitixorin (Primary) ; Bevacizumab; Fluorouracil; Oxaliplatin
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Isofol Medical

Most Recent Events

  • 16 Jul 2025 According to Isofol Medical media release, the company has successfully completed a pre-IND meeting with the U.S. Food and Drug Administration, FDA. The feedback from the FDA was positive,enable clinical development and commercialization of arfolitixorin in the U.S. The purpose of pre-IND meeting was to confirm that the ongoing Phase Ib/II study is appropriately designed according to FDA requirements and to receive the validation of the overall development program.
  • 02 Jun 2025 According to Isofol Medical media release, in the second part of this study, efficacy parameters will be the primary endpoints, for which an expansion of the study to additional countries is being planned. The USFDA, which is responsible for the approval of new treatments, has now granted Isofol's request for a Pre-IND meeting ahead of a planned submission of an Investigational New Drug (IND) application, to enable clinical development in the US.
  • 16 Apr 2025 New trial record

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