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New treatment option for Metastatic Colorectal Cancer (mCRC)
Official title A Clinical Study of Arfolitixorin in Patients With mCRC
ClinicalTrials.gov ID: NCT06922383
What this study is testing
What is Arfolitixorin?
Arfolitixorin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer (mcrc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed ICF and ability to comply with protocol requirements.
- Phase 1b: Histologically confirmed RAS mutant, MSS/pMMR, colorectal adenocarcinoma with metastatic disease, eligible for first-line therapy with...
- Patients with mutated RAS who are candidates for therapy with FOLFOX or FOLFIRI plus bevacizumab.
- Patients with WT RAS or WT BRAF and left-sided tumors who are candidates for therapy with FOLFOX or FOLFIRI plus cetuximab or panitumumab.
- Tumor specimen (formalin-fixed, paraffin-embedded [FFPE]) available.
You likely can't join if
- 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...
- Prior 5-FU, oxaliplatin, irinotecan, bevacizumab, cetuximab, or panitumumab administration for mCRC.
- 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...
See the full eligibility criteria
Who can join
- Signed ICF and ability to comply with protocol requirements.
- Phase 1b: Histologically confirmed RAS mutant, MSS/pMMR, colorectal adenocarcinoma with metastatic disease, eligible for first-line therapy with 5-FU, oxaliplatin, and bevacizumab regimen. Phase 2: Histologically...
- Patients with mutated RAS who are candidates for therapy with FOLFOX or FOLFIRI plus bevacizumab.
- Patients with WT RAS or WT BRAF and left-sided tumors who are candidates for therapy with FOLFOX or FOLFIRI plus cetuximab or panitumumab.
- Tumor specimen (formalin-fixed, paraffin-embedded [FFPE]) available.
- Acceptable hematologic laboratory values defined as: a) Hemoglobin ≥90 g/L. b) Absolute neutrophil count (ANC) ≥1.5 × 109/L. c) 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 and for at least 15 months (or longer if according to local labels) after study treatment...
- Female patients should agree to refrain from egg cell donation while on study treatment 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 and for at least 12 months (or longer if according to local labels) after study...
- Male patients should agree to refrain from sperm donation while on study treatment and for at least 12 months after the last dose of study treatment.
What rules you out
- 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...
- Prior 5-FU, oxaliplatin, irinotecan, bevacizumab, cetuximab, or panitumumab administration for mCRC.
- 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...
- 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, irinotecan, bevacizumab, cetuximab or panitumumab, 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 could lead to higher risk or otherwise make 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.
- Other structural heart disease (e.g., myocarditis, ventricular hypertrophy).
- New York Heart Association (NYHA) functional classification Class II or greater.
- QT prolongation syndrome \>450 ms.
- Slow or irregular ventricular rates; other serious arrhythmias requiring medication for treatment.
- Left ventricular ejection fraction (LVEF) \<55%.
- Active infection requiring i.v. antibiotics.
- Ongoing drug or alcohol abuse.
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg). Initiation of antihypertensives is permitted provided adequate control is documented over...
- Sensory peripheral neuropathy Grade ≥2.
- Pregnancy or lactation.
- Any medical condition, or ongoing treatment with contraindicated drugs, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or any psychological, familial...
- BRAF-mutant or deficient in mismatch repair (dMMR)/microsatellite instability-high (MSI-H) mCRC.
- Eligibility for treatment with FOLFIRINOX regimens.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Essen, Germany
- München, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Essen, Germany; München, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.