Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas

This is an interventional treatment trial for Inoperable Solid Tumors or Lymphomas Read More

Main Inclusion Criteria:

• Presence of inoperable tumor lesion/s from histologically confirmed solid tumors or lymphomas, in patients with at least one lesion ≥ 1 cm and suitable for intra-lesional injection, who have disease progression after treatment with available therapies, or who are intolerant to such treatments
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• If the patient received previous radiation therapy, the total absorbed radiation dose at the bone marrow level must be ≤ 1 Gy
• Life expectancy of at least 3 months
• Total tumor burden requiring ≤ 75 mL AvidinOX injection
• Clotting parameters within normal limits or maximum 25% outside of the the normal ranges
• Haematological and liver function test results ≤ grade 2 toxicity (according to US National Cancer Institute's Common Terminology) Criteria for Adverse Events v4.03 [CTCAE
• Urine protein (dipstick): negative or trace; in case of trace, a urinalysis has to be performed in the local laboratory and have to confirm that such abnormality is not to be considered clinically significant, according to the investigator's judgement
• Creatinine ≤ 1.7 mg/dL
• eGFR> 60% of mean age adjusted normal values
• Written informed consent

Main Exclusion Criteria:

• Known hypersensitivity to Avidin or AvidinOX (e.g. hen egg)
• Known hypersensitivity to ST2210 (DOTA biotin) or any excipient.
• Presence of unreachable (e.g. located in a region that cannot be reached by needle) or untreatable tumor 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.
• Patient who underwent chemotherapy, radiation therapy within 15 days before the screening period
• Previous treatment with 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 without a serum negative pregnancy test and not willing to refrain from sexual activity or to utilize an adeguate contraceptive methods during all the course of the study
• Men unwilling to use appropriate contraceptive methods during the study and up to six months follow-up period