PET-imaging of Two Vartumabs in Patients With Solid Tumors
Trial Parameters
Brief Summary
VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS). Oncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues. VAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.
Eligibility Criteria
General Inclusion Criteria: 1. Willing to adhere to the prohibitions and restrictions specified in this protocol. 2. Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol. 3. Patients aged ≥ 18 years at moment of signing informed consent form. 4. Life expectancy of \> 12 weeks. 5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1. 6. BMI ≥ 18.0 and ≤ 35.0 kg/m2 and weight at least 50 kg and no more than 120 kg at screening. 7. Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator. Note: one retest of vital functions and ECG is allowed within the screening window. 8. Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit