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Study identifier: NCT06922383 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Clinical Study of Arfolitixorin in Patients With mCRC

Condition: Metastatic Colorectal Cancer (mCRC)  ·  Sponsor: Isofol Medical AB

PhasePhase 1/Phase 2
Planned participants90
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a clinical research study taking place in Germany. Patients with colorectal cancer at a stage of the disease where metastases occur may take part in the study. A maximum of 90 people will participate in the study. There is already a standard therapy for treatment of colorectal cancer. This therapy contains a combination of the medicines leucovorin, fluorouracil, oxaliplatin/irinotecan and bevacizumab/cetuximab/panitumumab. The sponsoring company is developing the new therapy called arfolitixorin. In this study, patients with colorectal cancer will be given arfolitixorin instead of the standard treatment leucovorin. Different patients will receive treatment with different strengths (doses) of arfolitixorin. Treatment with fluorouracil, oxaliplatin/irinotecan and bevacizumab/cetuximab/panitumumab will also be administrated. The researchers want to find out if arfolitixorin could have an advantage over the standard therapy with leucovorin. They also want to investigate which dose of arfolitixorin is the maximum tolerated dose and if arfolitixorin is safe to use. The product being tested, arfolitixorin, like leucovorin, belongs to a group of substances called folates which are naturally occurring forms of a type of B vitamin. Folates are administered in combination with one or more chemotherapeutic agents to enhance their effect on cancer cells. The main mechanism of action of arfolitixorin is the same as that of leucovorin when used together with fluorouracil. Howev…

This description comes directly from the study's public registry record.

Talk to the study team

Roger Tell, MD, PhD  ·  +46760293911  ·  roger.tell@isofolmedical.com

Always discuss trial participation with your own doctor first.

Locations (3)

Charité - Universitaetsmedizin BerlinBerlin, GermanyRecruiting
Universitaetsklinikum Essen AöR, Department of Medical OncologyEssen, GermanyNot Yet Recruiting
Muenchen Klinik gGmbH, Klinik für Onkologie und HämatologieMünchen, GermanyNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06922383