Status:
RECRUITING
A Clinical Study of Arfolitixorin in Patients With mCRC
Lead Sponsor:
Isofol Medical AB
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Metastatic Colorectal Cancer (mCRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 60 people will part...
Detailed Description
This is a Phase 1b/2 study to determine the safety and preliminary efficacy of ARFOX + bevacizumab in patients with mCRC eligible for first-line therapy with 5-FU, oxaliplatin, and bevacizumab regimen...
Eligibility Criteria
Inclusion
- Signed ICF and ability to comply with protocol requirements.
- Histologically confirmed RAS mutant, MSS/pMMR, colorectal adenocarcinoma with metastatic disease, eligible for first-line therapy with 5-FU, oxaliplatin, and bevacizumab regimen.
- Tumor specimen (formalin-fixed, paraffin-embedded \[FFPE\]) available.
- Adequate heart function as defined as:
- Heart rate ≤100 bpm.
- Blood pressure ≤140/90.
- QTc ≤430 ms (males) or ≤450 ms (females).
- Ejection fraction (EF) \>50%.
- Acceptable hematologic laboratory values defined as:
- Hemoglobin ≥90 g/L.
- Absolute neutrophil count ≥1.5 × 109/L.
- Platelets ≥100 × 109/L.
- Adequate organ function as defined by the following laboratory values:
- Total serum bilirubin ≤1.5 × upper limit of normal (ULN).
- ALT and AST ≤3 × ULN (≤5 × ULN in case of hepatic metastases).
- Creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min (as measured according to Cockcroft-Gault equation).
- Age ≥18 years at the time of signing the ICF.
- Radiographically measurable disease per RECIST (version 1.1) within 28 days of treatment allocation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of \>12 weeks.
- Female patients must be surgically sterile, postmenopausal, or have negative results for a pregnancy test at screening, on a serum or urine sample obtained within 72 hours prior to initiation of study treatment.
- Female patients of childbearing potential must agree to use highly effective contraceptive measures while on study treatment (ARFOX + bevacizumab) and for at least 15 months (or longer if according to local labels) after study treatment discontinuation. Highly effective methods are those that achieve a failure rate of less than 1% per year when used consistently and correctly (as per the Clinical Trial Coordination Group \[CTCG\] Recommendations related to contraception and pregnancy testing in clinical trials, Version 1.2, 07 Mar 2024).
- Female patients should agree to refrain from egg cell donation while on study treatment (ARFOX + bevacizumab) and for at least 15 months after the last dose of study treatment.
- Male patients with female partners of childbearing potential must agree to use adequate contraceptive measures while on study treatment (ARFOX + bevacizumab) and for at least 12 months (or longer if according to local labels) after study treatment discontinuation.
- Male patients should agree to refrain from sperm donation while on study treatment (ARFOX + bevacizumab) and for at least 12 months after the last dose of study treatment.
Exclusion
- Indication for any mCRC surgery or anti-cancer treatment other than study treatment, including but not limited to resection as confirmed by a MTB.
- Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of signing consent. Patients with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer are permitted. Ongoing adjuvant antihormonal therapy after breast or prostate cancer is permitted.
- Prior 5-FU, oxaliplatin or bevacizumab administration for mCRC. Or more than 6 cycles (3 months) of oxaliplatin exposure during adjuvant treatment.
- Known history of central nervous system (CNS) metastases or carcinomatous meningitis.
- Receipt of any investigational product within 14 days or 5 half-lives prior to study treatment initiation, whichever is shortest. Note that participation in any other clinical study is not allowed as long as the patient is on study treatment.
- Prior exposure to arfolitixorin.
- Major surgery, or significant traumatic injury within 8 weeks of study treatment initiation.
- Hypersensitivity to arfolitixorin, 5-FU, oxaliplatin or other platinum agent, or bevacizumab or to their excipients.
- Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency test with a Clinical Pharmacogenetics Implementation Consortium (CPIC) activity score \<1.
- Current evidence of any condition that makes participating in this study not in the best interest of the patient, including, but not limited to:
- Myocardial infarction or unstable angina within the past 6 months.
- New York Heart Association (NYHA) Class II or greater cardiac disease.
- Congestive heart failure.
- QT prolongation syndrome \>430 ms (females) and \>450 ms (males).
- Serious arrhythmias requiring medication for treatment.
- Active infection requiring i.v. antibiotics.
- Ongoing drug or alcohol abuse.
- Sensory peripheral neuropathy Grade ≥2.
- Pregnancy or lactation.
- Any medical condition, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up schedule.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06922383
Start Date
April 10 2025
End Date
March 31 2029
Last Update
April 15 2025
Active Locations (1)
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1
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 10117