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OncoMatch/Clinical Trials/NCT06645808

PET-imaging of Two Vartumabs in Patients With Solid Tumors

Is NCT06645808 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including 89Zr-DFO-N-Suc-F8scFv and 89Zr-DFO-N-Suc-C9scFv for solid tumor.

Early Phase 1RecruitingVar2 PharmaceuticalsNCT06645808Data as of May 2026

Treatment: 89Zr-DFO-N-Suc-F8scFv · 89Zr-DFO-N-Suc-C9scFvVARTUTRACE 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Colorectal Cancer

Osteosarcoma

Non-Small Cell Lung Carcinoma

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

AST, ALT, and alkaline phosphatase  2.5x ULN; serum bilirubin  2.0x ULN (Gilbert disease:  3x ULN allowed)

Cardiac function

overtly healthy based on ECG at screening; LVEF 35%; no prolonged QTcF (450 ms), no cardiac arrhythmias or significant ECG abnormalities

Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit: AST, ALT, and alkaline phosphatase  2.5x ULN; serum bilirubin  2.0x ULN (Gilbert disease:  3x ULN allowed); INR or APTT  1.5x ULN (if not on anticoagulation); eGFR (based on plasma-creatinine) = 30 mL/min; serum albumin 35 g/L; overtly healthy based on ECG at screening; LVEF 35%; no prolonged QTcF (450 ms), no cardiac arrhythmias or significant ECG abnormalities

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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