Actively Recruiting
A Phase 1b/2 Study of Arfolitixorin as Part of 5-fluorouracil-based Treatment Regimens in the First-line Treatment of Metastatic Colorectal Cancer
Led by Isofol Medical AB · Updated on 2026-06-04
90
Participants Needed
3
Research Sites
56 weeks
Total Duration
On this page
Sponsors
I
Isofol Medical AB
Lead Sponsor
C
Charite University, Berlin, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying metastatic colorectal cancer (mCRC) to evaluate a new therapy called arfolitixorin. This study involves patients with colorectal cancer that has spread and compares arfolitixorin to the standard treatment leucovorin. The goal is to find out if arfolitixorin is safe, determine the best dose, and see if it may offer benefits over current therapies. Arfolitixorin is a folate-based drug designed to enhance chemotherapy effects, and it differs from leucovorin by being in an active form that may work better in some patients. The study is divided into two parts: Phase 1b and Phase 2. Phase 1b tests up to five doses of arfolitixorin to find the highest dose patients can tolerate and the best duration for administration, combined with chemotherapy drugs including fluorouracil, oxaliplatin or irinotecan, and antibodies like bevacizumab, cetuximab, or panitumumab. In Phase 2, two doses of arfolitixorin (one being the maximum tolerated dose from Phase 1b and one lower dose) will be compared to standard care using leucovorin. Treatments are given every two weeks as intravenous infusions and continue as long as patients benefit and tolerate them. Participants will undergo regular monitoring including physical exams, blood and urine tests, and imaging scans like CT or MRI to track tumor response and health status. Safety and side effects will be closely observed, with follow-up visits every three months after treatment ends for up to two years or until enough data is collected. Researchers will measure outcomes like safety, tumor shrinkage, duration of response, and overall survival to assess arfolitixorin's effects compared to standard therapy.
CONDITIONS
Brief Title
A Clinical Study of Arfolitixorin in Patients With mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and ability to follow study requirements.
- Histologically confirmed colorectal adenocarcinoma with metastatic disease.
- Eligible for first-line therapy with 5-FU based backbone treatments such as FOLFOX or FOLFIRI plus bevacizumab, cetuximab, or panitumumab.
- Tumor specimen available for analysis.
- Acceptable blood counts: hemoglobin 60 g/L, neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L.
- Adequate organ function including bilirubin 1.5 x ULN, ALT/AST 3 x ULN (or 5 x ULN if liver metastases), creatinine 1.5 x ULN or creatinine clearance 50 mL/min.
- Age 18 years or older at consent.
- Measurable disease by RECIST 1.1 within 28 days before treatment.
- ECOG performance status 0 or 1.
- Life expectancy over 12 weeks.
- Female participants must be surgically sterile, postmenopausal, or have a negative pregnancy test before starting.
- Women of childbearing potential must use highly effective contraception during and up to 15 months after treatment.
- Men with partners of childbearing potential must use contraception during and up to 12 months after treatment.
- Agreement to avoid egg or sperm donation during and post treatment as specified.
You will not qualify if you...
- Need for surgery or anti-cancer treatment other than study treatment.
- Other cancers within 2 years except certain treated skin or cervical cancers; controlled advanced prostate cancer allowed.
- Prior treatment with 5-FU, oxaliplatin, irinotecan, bevacizumab, cetuximab, or panitumumab for metastatic colorectal cancer.
- More than 6 cycles of oxaliplatin during prior adjuvant therapy.
- Known brain metastases or carcinomatous meningitis.
- Use of other investigational products within 14 days before study treatment.
- Prior exposure to arfolitixorin.
- Major surgery or serious injury within 8 weeks before starting treatment.
- Allergic reactions to study drugs or their components.
- DPD enzyme deficiency with activity score less than 1.
- Recent serious heart conditions or significant heart function abnormalities.
- Active infection needing intravenous antibiotics.
- Ongoing drug or alcohol abuse.
- Uncontrolled high blood pressure.
- Severe peripheral neuropathy (Grade 2 or higher).
- Pregnancy or breastfeeding.
- Conditions or treatments that increase risk or affect study participation.
- BRAF-mutant or mismatch repair deficient/microsatellite instability-high colorectal cancer.
- Eligibility for FOLFIRINOX treatment regimens.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until progressive disease or discontinuation
Participants receive arfolitixorin or leucovorin as part of eligible 5-FU based backbone treatment regimens every 14 days. Treatment continues until disease progression, clear clinical deterioration, or participant choice to stop.
Visits every 14 days during treatment
Duration - Up to 24 months post-treatment or until sufficient survival data collected
After treatment ends, participants complete an end of treatment visit within 30 days and are followed every 90 days to collect information on subsequent cancer treatments, adverse events, and survival status.
Visits or contacts every 90 days (±15 days) after end of treatment
Trial Site Locations
Total: 3 locations
1
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
2
Universitaetsklinikum Essen AöR, Department of Medical Oncology
Essen, Germany, 45147
Not Yet Recruiting
3
Muenchen Klinik gGmbH, Klinik für Onkologie und Hämatologie
München, Germany, 81737
Not Yet Recruiting
Research Team
R
Roger Tell, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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