Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
75
Countries
1
Sites
1
metastatic colorectal cancer
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician’s choice for 3rd line therapy for patients with metastatic colorectal cancer.
Key facts
- Sponsor
- Oncosyne AS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 28 Oct 2025 → ongoing
- Decision date (initial)
- 2025-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Others
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician’s choice for 3rd line therapy for patients with metastatic colorectal cancer.
Secondary objectives 3
- To evaluate the performance of μCAN to generate high quality, accurate, robust and reliable data intended as guidance in the physician’s choice for 3rd line therapy for patients with mCRC (Part A).
- To demonstrate compliance with the general safety and performance requirements for μCAN (Part A).
- To evaluate the device user experience for μCAN (Part A).
Conditions and MedDRA coding
metastatic colorectal cancer
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part A – µCAN report evaluation All mCRC patients treated at the participating study site may be considered eligible for study participation based on the judgement of the recruiting Investigator.
Tumour samples will be taken according to best practice procedures at the tumour sampling site. Tumour samples will be sent to Oncosyne for µCAN processing and analysis. A µCAN report will typically be available to the Investigator within 8 weeks from when the tumour sample was taken.
|
Not Applicable | None | ||
| 2 | Part B – Exploratory clinical evaluation of µCAN Patients who complete Part A, are eligible and who consent to participation in Part B, will be randomised to receive µCAN guided therapy or SoC therapy for their next line of therapy.
|
Randomised Controlled | None | µCAN guided therapy: Patients randomised to this arm (µCAN guided therapy) will have a µCAN report available. Treating physician may use the report as reference when deciding next in line treatment. Treatment is per phycisians decision and may, or may not, include a drug listed in the report. 30 patients are expected to enter this arm. SoC therapy: Patients randomised to this arm will be treated according to SoC for their disease. Treating physician will not have a report for reference. 15 patients are expected to enter this arm. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.
- Male or female patients, ≥18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, who have metastatic lesions in the liver or peritoneum (or lymph nodes) that are radiologically assessable and can be biopsied, and who have recently failed 1st-line systemic therapy (2nd line for patients with three standard therapy lines) for unresectable metastatic disease and will shortly commence a new line of standard therapy.
- Patient is eligible for another line of tumour directed therapy on failure of the SoC.
- Patient has the following laboratory values, as measured in serum/plasma within 14 days prior to signing of informed consent for participation in Part A and B, respectively, indicative of adequate organ function: (see protocol for full laboratory values).
Exclusion criteria 4
- Life expectancy < 3 months.
- Planned treatment or treatment with another investigational drug or investigational device within 3 months prior to the day of the tumour sampling procedure.
- Patients who are pregnant, or currently breastfeeding.
- Investigator considers the patient unlikely to comply with clinical performance study procedures, restrictions and requirements.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients with a successful biopsy yielding a µCAN report.
Secondary endpoints 5
- Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks).
- Proportion of patients with a successful biopsy yielding a µCAN report with at least one drug therapy nomination.
- Frequency, intensity and seriousness of adverse events (AEs) related to device or study procedures.
- Frequency and nature of device deficiencies (DD).
- Device user experience questionnaire.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INFUSION
- Max daily dose
- 000
- Max total dose
- 000
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncosyne AS
- Sponsor organisation
- Oncosyne AS
- Address
- Ullernchausseen 64
- City
- Oslo
- Postcode
- 0379
- Country
- Norway
Scientific contact point
- Organisation
- Oncosyne AS
- Contact name
- Information desk
Public contact point
- Organisation
- Oncosyne AS
- Contact name
- Information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Akershus University Hospital
Department of Oncology, Sykehusveien 25, 1474, Loerenskog
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2025-10-28 | 2025-10-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519600-27-00_redacted | 5.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Fase 2_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_5-Fluorouracil | 0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NOR_2024-519600-27-00 | 2 |
| Synopsis of the protocol (for publication) | D4_Patient facing document_EORTC QLQC30 | 3 |
| Synopsis of the protocol (for publication) | D4_Patient facing document_EQ-5D-5L | 0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Norway | Acceptable 2025-04-29
|
2025-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-23 | Norway | Acceptable 2026-05-11
|
2026-05-11 |