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
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Lead
Alfasigma S.p.A.
The primary objectives of this study are:
1. To identify the Maximum Tolerated Dose (MTD) of two consecutive repeated IV 177Lu-ST2210 administration following a previous tumor intra-lesion/s injection of AvidinOX.
2. To assess safety and tolerability of intra-lesionally injected AvidinOX + IV injected 177Lu-ST2210
3. To evaluate intra-lesional distribution and retention of {AvidinOX + 177Lu-ST2210}-complex in tumor lesion/s
4. To evaluate systemic biodistribution and pharmacokinetics of 177Lu-ST2210 and {AvidinOX + 177Lu-ST2210}- complex
Main secondary objectives are:
1. To evaluate whole body dosimetry of IV 177Lu-ST2210 after prior AvidinOX injection (radiation safety dosimetry)
2. To record individual tumor dosimetry
3. To evaluate preliminary efficacy of {AvidinOX + 177Lu-ST2210}-complex in reducing tumor size and metabolic activity.
4. To evaluate damage of tumor cells by radioactivity and immunogenic cell death
5. To evaluate whole body safety dosimetry and dose linearity
6. To evaluate pharmacokinetics of ST2210 in plasma and urine
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
