RecruitingEarly Phase 1NCT06645808

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

Sponsor

Var2 Pharmaceuticals

Enrollment

32 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Bladder Carcinoma Esophageal Carcinoma Gastric Carcinoma Lung Carcinoma Head and Neck Squamous Cell Carcinoma Solid Tumor Osteosarcoma Colon Carcinoma Rectal Carcinoma Chondrosarcoma Pancreas Carcinoma Glioblastoma Soft Tissue Sarcoma (STS)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using PET scan imaging with two experimental tracers (called vartumabs) to visualize and study solid tumors. The goal is to understand how well these imaging agents can detect certain proteins on cancer cells, which may help guide future targeted treatments. **You may be eligible if...** - You are 18 years or older - You have a solid tumor and life expectancy of more than 12 weeks - You are in good physical health (ECOG score 0 or 1) - Your weight is between 50–120 kg and BMI is between 18–35 - Your liver, kidney, and blood function meet required levels - For women: you are post-menopausal or surgically unable to become pregnant **You may NOT be eligible if...** - You have significant liver or kidney problems outside the stated thresholds - You have unstable health conditions that would make participation unsafe - You are pregnant or breastfeeding - You do not meet the weight/BMI requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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