64Cu-LNTH-1363S in Patients with Sarcoma or Gastrointestinal Tract Cancer

Eligibility Criteria

• 1. Patient must be ≥ 18 years of age and must have provided written informed consent.
• 2. Patients with suspected FAP-expressing metastatic sarcoma.
• 3. Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
• 4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
• 5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
• 6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
• 7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.
• 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
• 2. Known pregnancy or breastfeeding.
• 3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
• 4. They are participating as patients in another clinical study with an Investigational Product or another systemic therapy administered in the last 3 weeks.
• 5. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
• 6. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \> 450 milliseconds) or taking medications known to cause QT/QTc prolongation.
• 7. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
• 8. Have history of QT prolongation or is taking a medication known to cause QT prolongation.