Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

Korábbi kezelés

• Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-DFO\*-89Zr, or continuing adverse effects (\>grade 1, excluding alopecia, anorexia, fatigue, and neuropathy) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
• Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 effective half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-DFO\*-89Zr.

Más betegség

• Other serious, non-malignant diseases that may interfere (e.g., renal, hepatic, or hematologic) with the objectives of the study, safety, or compliance, as judged by the investigator.
• Cognitive impairment or contraindications that may compromise the ability to give informed consent or comply with the requirements of the study.

Laborértékek

• Have evidence of impaired organ function at Screening and within 1 week prior to dosing MNPR-101-DFO\*-89Zr, particularly:
  • Bone marrow i. Platelets \<75 K/mcL. ii. ANC \<1.0 K/mcL.
  • Liver function i. AST/ALT \>2.5xULN (institutional upper limits of normal) OR \>5×ULN for patients with liver metastases.
  • Bilirubin \>1.5xULN OR \>3×ULN for patients with known Gilbert's Syndrome.
  • Renal function i. eGFR ≤45 mL/min determined using BSA-adjusted Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\].

• Histologically and/or cytologically confirmed solid tumor cancer.
• Age ≥18 years.
• Measurable disease ≥ 1 cm on prior 18F-FDG PET/CT scan. Up to 4 subjects may be enrolled with FDG-avid disease which do not meet ≥ 1 cm measurement on CT.
• Ability to understand and willingness to sign a written informed consent document.
• A prior standard-of-care 18F-FDG PET/CT scan within past 60 days.
• Tumor sample available for IHC testing to demonstrate uPAR expression.
• Females of childbearing potential must have a negative serum pregnancy test at time of screening and a negative urine pregnancy test on Day 1 prior to study drug administration if screening is \>7 days prior to Day 1. A rapid serum pregnancy test result performed as standard-of-care will be accepted if available.
• Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 1 month after dosing.
• Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 1 month following the last dose of study drug.