131Iodine-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients

Inclusion Criteria

• •1\. Written informed consent.
• •2\. A patient who has (a) a histologically documented advanced tumor that has relapsed from, or is refractory to, standard treatment and for which no other standard treatment is available and (b) confirmed Tenascin-C expression obtained through a biopsy on at least one reachable tumor lesion.
• •These patients will have failed one or more prior therapeutic line and had assessable and measurable disease expression, but were not considered eligible for other standard approaches with curative intent, as assessed by the Investigator.
• •3\. Agreement to hemopoietic stem cell collection procedures (the procedure will be performed upon clinical evaluation of the Investigator and if deemed necessary in the interest of the patient).
• •4\. Male or female ≥18 years of age
• •5\. Eastern Cooperative Oncology Group (ECOG), or WHO performance status of ≤ 2 or Karnofsky \> 60
• •6\. Life expectancy of at least 3 months.
• •7\. Negative pregnancy test for all women of child-bearing potential. Appropriate contraception (one highly effective method or a combination of acceptable methods) is to be used during the study period and until 90 days after the last follow-up visit (End of Study Visit)
• •8\. Hematological, thyroid, liver, cardiac and renal function test results ≤ grade 2 toxicity (according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events v4.03 \[CTCAE\]"), e.g.:
• •Haematology:
• •Hematocrit ≥ 30%
• •Hemoglobin ≥ 9.0 g/dl
• •White blood cell count ≥ 3 x 109/L
• •Neutrophils \> 1.5 x109/L
• •Platelets ≥ 100x 109/L
• •Thyroid:
• •\- Free-Triiodothyronine and Free-Thyroxine ≤ 3 times upper limit of normal or \>3 times lower limit of normal.
• •Liver:
• •Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase ≤ 2.5 times institutional upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases.
• •Bilirubin ≤ 1.5 x ULN or ≤3 x ULN in presence of liver metastases.
• •Renal:
• •Urine protein: ≤30 mg/dl or dipstick: ≤3
• •eGFR≥60 ml/min/1.73 m2 (with Chronic kideny disease-Epidemiology collaboration formula)
• •Cardiac
• •Resting Ejection Fraction (EF) ≥ 50%