drugset / Trial / NCT06645808

PET-imaging of Two Vartumabs in Patients With Solid Tumors

NCT06645808 ↗

Phase 0 Recruiting 32 enrolled Var2 Pharmaceuticals TRACER Europe BV · collab
Non-randomizedSequentialOpen-labelOther

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.

Timeline

Start
2024-12-10
Primary completion
2026-08
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject 89Zr-DFO-N-Suc-C9scFv Protein / enzyme biologic 1 mg Intravenous
Subject 89Zr-DFO-N-Suc-C9scFv Protein / enzyme biologic 15 mbq Intravenous
Subject 89Zr-DFO-N-Suc-C9scFv Protein / enzyme biologic 30 mbq Intravenous
Subject 89Zr-DFO-N-Suc-F8scFv Protein / enzyme biologic 1 mg Intravenous
Subject 89Zr-DFO-N-Suc-F8scFv Protein / enzyme biologic 15 mbq Intravenous
Subject 89Zr-DFO-N-Suc-F8scFv Protein / enzyme biologic 30 mbq Intravenous