89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors

Inclusion Criteria

• •All participants must meet the following criteria:
• •1. Written and voluntarily given Informed Consent.
• •2. Male or female ≥18 years of age at time of consent.
• •3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
• •4. Participants must have proven tumors of the following types, but not limited to:
• •* Cervical cancer;
• •* Colorectal cancer;
• •* Esophageal SCC and esophageal/esophagogastric junction adenocarcinoma;
• •* Gastric adenocarcinoma;
• •* GBM;
• •* Head and neck SCC and nasopharyngeal carcinoma;
• •* cholangiocarcinoma and hepatocellular carcinoma;
• •* non-small cell lung cancer;
• •* small cell lung cancer;
• •* epithelial ovarian carcinoma;
• •* pancreatic ductal adenocarcinoma;
• •* Soft tissue sarcoma;
• •* malignant mesothelioma;
• •* confirmed diagnosis of VHL disease with VHL germline alteration and at least one VHL-related lesion.
• •5. Have at least one non-central nervous system (CNS), measurable target lesion as defined per RECIST 1.1 and documented by SOC conventional imaging, performed within 60 days (+14 days) prior to Day 0 (excepting participants with GBM or hemangioblastoma, given that all lesions may be in the CNS, such lesions assessed by RANO);
• •6. Have agreed not to receive another investigational product while participating in the present study, defined as signing the informed consent form (ICF), until completion of the last study visit;
• •7. Have negative serum pregnancy tests if a female of childbearing potential at screening and have a confirmatory negative urine pregnancy test result within 24 hours prior to receiving investigational product. Female participants of non-child- bearing potential must provide evidence by fulfilling one of the following criteria at screening:
• •* Be post-menopausal, defined as more than 50 years of age and amenorrheic for at least 12 months since cessation of all exogenous hormonal treatments;
• •* Be a woman under 50 years of age and considered postmenopausal given amenorrhea for 12 months or more since cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range by institutional SOC;
• •* Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation; and
• •8. Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration