Study of Arfolitixorin Compared to Standard Therapy with Leucovorin in Metastatic Colorectal Cancer Using 5-Fluorouracil-Based Chemotherapy Regimens

What this Trial Is About

Researchers are investigating a new therapy called arfolitixorin for patients with metastatic colorectal cancer mCRC who are eligible for first-line treatment. This Phase 1b2 study aims to evaluate the safety, tolerability, and preliminary efficacy of arfolitixorin when given in place of leucovorin, a standard therapy component, in combination with other chemotherapy drugs. The study compares different doses of arfolitixorin to determine the maximum tolerated dose and optimal administration duration while assessing its potential advantages over the current standard treatment. Participants will receive arfolitixorin or leucovorin as part of chemotherapy regimens including fluorouracil, oxaliplatin or irinotecan, and antibody treatments such as bevacizumab, cetuximab, or panitumumab. Treatment is administered via intravenous infusions every two weeks. The study has two parts the first identifies the maximum tolerated dose of arfolitixorin through dose escalation, and the second randomly assigns patients to two arfolitixorin dose groups or a standard treatment group to evaluate safety and anti-tumor effects. Throughout the trial, patients undergo imaging scans such as CT or MRI to monitor tumor response and disease progression at baseline, 6 and 12 weeks, and every 12 weeks thereafter. Physical exams, blood and urine tests, and side effect assessments are conducted regularly. After treatment ends, participants have an end-of-treatment visit and are followed up every 90 days to track survival, subsequent treatments, and any ongoing adverse events, with total follow-up lasting up to 24 months.

A Clinical Study of Arfolitixorin in Patients With mCRC