Study 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

Study Details

Description:

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.

Sponsor:

Var2 Pharmaceuticals

Drug Details

C9scFv
Isotope(s):
    ZIRCONIUM-89
    Radioisotope: Zr89
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 78 Hours
    Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
    Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
    Range: N/A
    Decay Daughters: Y89 (Stable)
    Status: Clinical Trials Only
  • ZIRCONIUM-89
Target(s):
  • Chondroitin Sulfate
Ligand: Small Protiens and Antibody Fragments
F8scFV
Isotope(s):
    ZIRCONIUM-89
    Radioisotope: Zr89
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 78 Hours
    Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
    Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
    Range: N/A
    Decay Daughters: Y89 (Stable)
    Status: Clinical Trials Only
  • ZIRCONIUM-89
Target(s):
  • Chondroitin Sulfate
Ligand: Small Protiens and Antibody Fragments

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