Clinical trial NCT06645808: PET-imaging of Two Vartumabs in Patients With Solid Tumors
Official title: The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients With Solid Tumors - a Phase 0, Open Label, PET/CT Molecular Imaging Basket Trial
Conditions: Solid Tumor
Colon Carcinoma
Rectal Carcinoma
Osteosarcoma
Chondrosarcoma
Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Gastric Carcinoma
Pancreas Carcinoma
Bladder Carcinoma
Glioblastoma
Soft Tissue Sarcoma (STS)
Breast Cancer
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.
Interventions:
description: 89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.
name: 89Zr-DFO-N-Suc-F8scFv
type: Biological
description: 89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.
name: 89Zr-DFO-N-Suc-C9scFv
type: Biological
description: IMP administration will be followed by PET/CT scans on day 1, 2 and 4.
name: PET/CT scan
type: Radiation
Study arms:
design_group_description: The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-F8scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose.<br/>The following 13 patients will receive a single i.v. microdose administration of 89Zr-F8scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.
design_group_title: 89Zr-F8scFv
design_group_type: Experimental
design_group_description: The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-C9scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose.<br/>The following 13 patients will receive a single i.v. microdose administration of 89Zr-C9scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.
design_group_title: 89Zr-C9scFv
design_group_type: Experimental
Sponsor: Var2 Pharmaceutical
Collaborators: Tracer Europe BV
Drug name mappings:
name: Zirconium-89 Labelled Vartumab
lang: EN