OncoMatch/Clinical Trials/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
Is NCT06645808 recruiting? Yes, currently enrolling (Oct 2026). This Early Phase 1 trial studies multiple treatments including 89Zr-DFO-N-Suc-F8scFv and 89Zr-DFO-N-Suc-C9scFv for solid tumor.
Treatment: 89Zr-DFO-N-Suc-F8scFv · 89Zr-DFO-N-Suc-C9scFv — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Colorectal Cancer
Osteosarcoma
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Gastric Cancer
Urothelial Carcinoma
Glioblastoma
Sarcoma
Breast Carcinoma
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
INR or APTT ≤ 1.5x ULN (if not on anticoagulation); serum albumin 35 g/L
Kidney function
eGFR (based on plasma-creatinine) = 30 mL/min
Liver function
Exact limits: see the full eligibility criteria on this page.
Cardiac function
overtly healthy based on ECG at screening; LVEF 35%; no prolonged QTcF (450 ms), no cardiac arrhythmias or significant ECG abnormalities
Exact limits: see the full eligibility criteria on this page.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06645808 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage I or II or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages