Actively Recruiting
Safety, Tolerability, and Biodistribution of Two Zirconium-89 Labeled Vartumabs in Patients With Solid Tumors: Phase 0 PET/CT Molecular Imaging Basket Trial
Led by Var2 Pharmaceuticals · Updated on 2025-12-29
32
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
V
Var2 Pharmaceuticals
Lead Sponsor
T
TRACER Europe BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two antibody fragments that target oncofetal chondroitin sulfate (CS), a tumor-specific marker found in most cancers but not in healthy tissues. This Phase 0 PET/CT molecular imaging study aims to investigate how these radiolabeled antibody fragments distribute, accumulate in tumors, and are cleared from the body in patients with solid tumors. The study focuses on biodistribution, pharmacokinetics, pharmacodynamics, and safety in a diverse group of cancer patients. Participants will receive a single intravenous microdose of one of two radiolabeled antibody fragments named 89Zr-F8scFv or 89Zr-C9scFv. Initially, the first three patients in each group receive a set dose followed by three whole-body PET/CT scans on days 1, 2, and 4 to determine the best scanning schedule and radiation dose. Subsequent patients receive a dose between 15 to 30 MBq followed by one PET/CT scan on the optimal day. Each participant has a follow-up visit about 28 days after receiving the study drug. During the study, participants undergo whole-body PET/CT scans to track the antibody fragments, and researchers monitor tumor-specific uptake and overall safety through adverse event reporting up to 56 days. The study includes assessments of liver and kidney function, vital signs, and ECG. Researchers plan to analyze pharmacokinetics and tumor targeting across multiple cancer types, with total participation spanning from dosing to about one month of follow-up.
CONDITIONS
Brief Title
PET-imaging of Two Vartumabs in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to follow study rules and restrictions
- Able to give informed consent voluntarily
- Aged 18 years or older at consent
- Life expectancy greater than 12 weeks
- ECOG performance status of 0 or 1
- Body mass index between 18.0 and 35.0 kg/m2, weight between 50 and 120 kg
- Healthy based on medical history, exam, vital signs, and ECG
- Adequate liver and kidney function based on lab tests
- No clinically significant lab abnormalities
- Female participants must be at least 1 year post-menopausal or surgically sterile
- Males with female partners of childbearing potential must use effective birth control and not donate sperm for 3 months after study drug
- Diagnosed with specific solid tumors (colon, rectal, bone or soft-tissue sarcoma, breast, lung, head and neck, oesophageal, gastric, pancreas, bladder, glioblastoma) with confirmed histology or cytology
- Undergoing neo-adjuvant treatment as standard care
You will not qualify if you...
- Behavioral, cognitive, or psychiatric conditions affecting study compliance
- Insufficient venous access
- Close relation or dependency with the investigator or study staff
- Any medical condition that poses high risk or affects study results
- Participation in other interventional studies within 30 days
- Second active malignancy or treatment within 1 year, except cured basal or squamous cell cancer
- Cardiac impairment or significant ECG abnormalities
- Unstable vital signs
- Recent major surgery unrelated to tumor within 4 weeks
- Active infection or recent antibiotic use within 7 days
- Planned major surgery during study period
- Prior bone marrow or solid organ transplant
- History of anaphylaxis or significant allergies to study drugs or components
- Any other condition contraindicating study drug use or affecting safety or results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive a single intravenous microdose of one of two radiolabeled antibody fragments (89Zr-F8scFv or 89Zr-C9scFv) targeting tumor-specific markers, followed by PET/CT scans to assess biodistribution and tumor uptake.
3 PET/CT scan visits on day 1, 2, and 4 for the first 3 patients; 1 PET/CT scan visit on an optimal day between day 1 and 7 for remaining participants
Duration - Approximately 28 days after treatment
Participants return for a follow-up visit approximately 28 days after dosing to assess safety and tolerability.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen (UMCG)
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
A
Anne-Fleur Verhaar, MD
N
Noortje van Dijk, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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