PET-imaging of Two Vartumabs in Patients With Solid Tumors

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.

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

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.

Sponsors & Collaborators

• TRACER Europe BV

  collaborator INDUSTRY

• Var2 Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Gooitzen van Dam, MD, PhD · TRACER Europe B.V.

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-10

Primary Completion

2026-08-31

Completion

2026-09-30

Countries

• Netherlands

Study Locations