Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT03188328
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03188328
Study Brief:
Protocol Section:
NCT03188328