Actively Recruiting
Clinical Performance Study of a New Diagnostic Test for Drug Sensitivity Evaluation in Metastatic Colorectal Cancer
Led by Oncosyne AS · Updated on 2026-04-30
75
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oncosyne AS
Lead Sponsor
U
University Hospital, Akershus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new diagnostic test called 6CAN designed to help guide treatment for patients with metastatic colorectal cancer. This test uses a cancer biopsy sample to grow patient-derived tumoroids and combines advanced machine learning and imaging techniques to find the best drug options for each patient. The study is a public-private partnership between Norwegian and Swedish organizations aiming to improve treatment outcomes, increase survivability, and reduce costs in cancer care. The study compares two groups: one where the treating physician may use the 6CAN diagnostic drug screen report to guide therapy, and another receiving the standard combination treatment of trifluridine/tipiracil/bevacizumab in 28-day cycles. The 6CAN guided therapy may include clinically relevant on-label or off-label drugs based on drug screening of patient tumoroids. Treatment and monitoring follow each patient's assigned group. Participants will undergo a biopsy to obtain tumor samples for the 6CAN test and receive treatment as per their assigned group. Researchers will monitor the success rate of obtaining usable 6CAN reports within about 6 months, along with any adverse events related to the test or study procedures. The study tracks outcomes such as therapy nominations from the test and safety data, with the total participation lasting approximately 6 months.
CONDITIONS
Brief Title
Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent for study participation
- Male or female patients aged 18 years or older
- ECOG performance status 0-1
- Metastatic lesions in liver, peritoneum, or lymph nodes that are radiologically assessable and biopsiable
- Recently failed 1st line systemic therapy (or 2nd line for patients with three standard therapy lines) for unresectable metastatic disease
- Eligible for another line of tumor-directed therapy after standard-of-care failure
- Laboratory values within specified limits indicating adequate organ function (including hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, albumin, INR, creatinine)
- For Part A: compliance with contraceptive requirements as per treatment SmPC
- For Part B: women of childbearing potential must use highly effective contraception or abstinence; male partners must use condom or be vasectomized
- Women of non-childbearing potential defined by surgical history or menopause status
- Male participants must use condom, be vasectomized, or practice sexual abstinence to prevent pregnancy
You will not qualify if you...
- Life expectancy less than 3 months
- Planned treatment or treatment with another investigational drug or device within 3 months prior to tumor sampling
- Pregnant or currently breastfeeding
- Investigator considers patient unlikely to comply with study procedures and requirements
- For Part B only: no 6CAN report from Part A
- For Part B only: not eligible for trifluridine/tipiracil/bevacizumab therapy
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 - Up to 8 weeks
Participants undergo a biopsy to obtain tissue samples for the µCAN drug screen test to identify the best drug therapies.
1 to 2 visits depending on biopsy and testing procedures
Duration - Approximately 6 months
Participants receive therapy guided either by the µCAN diagnostic test results or the standard-of-care drug combination, trifluridine/tipiracil/bevacizumab in 28-day cycles.
Repeated visits for treatment cycles over approximately 6 months
Trial Site Locations
Total: 1 location
1
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Actively Recruiting
Research Team
J
Jarle Bruun, PhD
P
Peter W Eide, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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