NCT06645808

PET-imaging of Two Vartumabs in Patients With Solid Tumors

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Var2 Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

VARTUTRACE aims to investigate the biodistribution and pharmacology in patients with solid tumors of two antibody fragments specific for oncofetal CS. VAR2 Pharmaceuticals has identified and characterized oncofetal CS as a group of tumor-specific carbohydrate motifs that appear in placental tissue during fetal development and in most cancers while remaining largely absent from healthy tissue. VAR2 Pharmaceuticals recently developed a panel of antibodies specific for oncofetal CS and characterized their tumor specificity, therapeutic, and safety in pre-clinical models under various formats. VARTUTRACE is a Phase 0 microdosing study of a single administration of \<30 nmol of one of the two most promising antibody fragments identified by VAR2 Pharmaceuticals - C9 and F8. Both antibody fragments will be used as short chain variable fragments (scFvs) labelled with the radioisotope Zirconium-89 (89Zr) and are therefore respectively named 89Zr-C9scFv or 89Zr-F8scFv. As it remains unclear from the pre-clinical in vitro and in vivo data which of the two will have the most optimal tumor targeting properties in patients with solid tumors, both scFvs will be evaluated. The biodistribution, pharmacokinetics, pharmacodynamics, and clearance of two of these antibody fragments is planned to be studied in up to 32 patients with various cancers (i.e. a 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

Interventions

Type	Name	Description
BIOLOGICAL	89Zr-DFO-N-Suc-F8scFv	89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.
BIOLOGICAL	89Zr-DFO-N-Suc-C9scFv	89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.
RADIATION	PET/CT scan	IMP administration will be followed by PET/CT scans on day 1, 2 and 4.

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2024-10-17
• Last updated: 2025-12-29

Locations

1 site across 1 country: Netherlands