Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer

Official title

Clinical Performance Study of a New Diagnostic Test for Drug Sensitivity Evaluation in Metastatic Colorectal Cancer

Overview

DSEE-CRC is a top-tier Norwegian and Swedish public-private partnership for the development of µCAN, a unique patient-centric, therapy-guiding in vitro diagnostic test to improve cancer treatment outcomes for metastatic colorectal cancer patients. µCAN takes a cancer biopsy sample as input and combines proprietary patient-derived tumoroid culturing conditions with state of-the-art machine learning, and computer-vision guided fluorescence high- content drug screening and analysis, to identify the best therapeutical approach for clinical practice. DSEE-CRC will have a positive societal and financial impact and directly contributes to the Good Health and Well-being Sustainable Development Goals by delivering patient-tailored treatments, concurrently increasing cancer survivability rates, improving patients' quality of care, and reducing cancer treatment costs for healthcare providers.

Interventions

• Diagnostic test µCAN drug screen test
  µCAN guided therapy is based on drug screening of patient-derived tumoroids. The patient might be treated with clinically relevant on-label or off-label drugs
• Other Standard-of-Care Therapy
  trifluridine/tipiracil/bevacizumab combination, 28 day cycles

Primary outcome measures

• Proportion of patients with a successful biopsy yielding a µCAN report. [Time frame: Through completion of study Part A, an average of 6 months]

Secondary outcome measures (4)

• Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks). [Time frame: Through completion of study Part A, an average of 6 months]
• Proportion of patients with a successful biopsy yielding a µCAN report with at least one drug therapy nomination. [Time frame: Through completion of study Part A, an average of 6 months]
• Frequency, intensity and seriousness of adverse events (AEs) related to device or study procedures. [Time frame: Through completion of study Part A, an average of 6 months]
• Frequency and nature of device deficiencies (DD). [Time frame: Through completion of study Part A, an average of 6 months]

Eligibility criteria

Inclusion criteria

• 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:

• Haemoglobin at least 10.0 g/dL.
• Neutrophils at least 1.5 x109/L (without current use of colony-stimulating factors).
• Platelets at least 100 x109/L.
• AST/ALT no higher than 2xULN when patient does not have metastatic disease in the liver, or no higher than 5xULN when patient has metastatic disease in the liver.
• Bilirubin no higher than 1.5xULN when patient does not have metastatic disease in the liver, or no higher than 2xULN when patient has metastatic disease in the liver.
• Albumin no lower than 30 g/L.
• INR within normal level.
• Creatinine no higher than 1.5xULN.
• For Part A: the treating physician should follow contraceptive requirements described in the SmPC of respective treatment.
• For Part B: women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of <1 % to prevent pregnancy from at least 2 weeks prior to the screening visit of Part B to 4 weeks after the last administration of IMP in Part B. In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom from the screening visit of Part B until 4 weeks after the last administration of IMP in Part B.

The following are considered highly effective methods of contraception:

• combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
• intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]) WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration. WOCBP with an exclusive male partner who has undergone vasectomy may chose not to use contraceptives.

Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone \[FSH\] >25 IU/L is confirmatory). Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 4 weeks after the last administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP.

Exclusion criteria

• 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.
• Part B only: no µCAN report was generated from Part A.
• Part B only: Patient is not eligible for trifluridine/tipiracil/bevacizumab combination therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Norway · 1 center

• Akershus University Hospital — Lørenskog

Identifiers

NCT: NCT07171554 · DSEE-CRC · 2024-519600-27-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗