Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female ≥ 18 years of age
Liver metastases from histologically confirmed colorectal cancer and at least one liver metastasis ≥ 1 cm (measurable disease), which is chemo-resistant, not eligible for curative surgery and suitable for intra-lesional injection as assessed by the investigator.
Total liver tumor burden requiring ≤ 75 ml AvidinOX
Maximum of 9 liver metastases
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Life expectancy of at least 3 months.

Clotting parameters as follows, with local normal ranges to be taken as reference:

Prothrombin Time (Quick).Patients showing an increase of the Upper Limit of the Normal (ULN) range of about 20% can also be considered for inclusion.
International Normalised Ratio (INR). Patients showing an increase of the ULN of about 20% can also be considered for inclusion
Activated Partial Thromboplastin Time (aPTT). Patients showing an increase of the ULN of about 20% can also be considered for inclusion
Fibrinogen. Patients showing a decrease of the Lower Limit of the Normal range (LLN) of about 20% can also be considered for inclusion.

Haematological, liver and renal function test results ≤ grade 2 toxicity (according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events v4.03 [CTCAE]"), i.e.:

Haematology:

Haemoglobin ≥ 8 g/dl
White blood cell count ≥ 2 x 109/L
Platelets ≥ 80x 109/L

Liver:

Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP) ≤ 5 times upper limit of normal
Bilirubin ≤ 3 times upper limit of normal

Renal:

Urine protein dipstick: 0
estimated Glomerular Filtration Rate (eGFR)> 30 ml/min/1.73 m2 (with CKD-EPI formula)
Written informed consent

Exclusion Criteria:

Known hypersensitivity to Avidin or AvidinOX (e.g. hen egg)
Known hypersensitivity to ST2210(DOTA biotin) or any excipient.
Life limiting metastases outside the liver. Metastases outside the liver are allowed only in case the residual metastases (after liver treatment) are amenable to further treatments (e.g. surgical removal)
Presence of unreachable (e.g. located in a region in the liver that cannot be reached by needle, or too close to major blood vessels or adjacent to main organs) or untreatable hepatic lesions so that the benefit from the treatment of the treatable lesions does not justify patient's inclusion
Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator
Known human immunodeficiency virus (HIV) positive serology or chronically active hepatitis B or C.
Administration of another investigational medicinal product within 30 days before the screening period.
Previous treatment with Selective Internal Radiation Therapy (SIRT) spheres or any radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used for labeling the respective radiopharmaceutical prior to the administration of study drug.
Women of child-bearing potential. A permanent postmenopausal status must be proven as follows: history of hysterectomy or hormone analysis in serum: estradiol < 20 pg/ml and follicle stimulating hormone (FSH) > 40 IU/L, or amenorrhea starting at least 1 year prior to the study start andnegativeβHCG .
Men unwilling to use appropriate contraceptive methods during the study and up to six months after the end of the study
Inability or unwillingness to be catheterized
History of somatic or psychiatric disease/condition that may interfere with the objectives of the study
Clinically significant illness or clinically relevant trauma within 15 days before the screening period
Patient who underwent chemotherapy, radiation therapy within 15 days before the screening period