Actively Recruiting
PET-imaging of Two Vartumabs in Patients With Solid Tumors
Led by Var2 Pharmaceuticals · Updated on 2025-12-29
32
Participants Needed
1
Research Sites
90 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
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.
CONDITIONS
Official Title
PET-imaging of Two Vartumabs in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to follow all study restrictions and requirements.
- Able to provide signed informed consent.
- 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.
- Generally healthy based on medical history and screening tests.
- Adequate liver and kidney function with specific lab value limits.
- No other significant abnormal lab results.
- Female participants must be at least 1 year post-menopausal or surgically sterile.
- Male participants sexually active with female partners must use birth control and avoid sperm donation until 3 months after study drug administration.
- Diagnosed with specified solid tumors (colon, rectal, bone or soft tissue sarcoma, breast, lung, head and neck squamous cell carcinoma, esophageal, gastric, pancreas, bladder carcinoma, or glioblastoma) at stages I-IV.
- Histologically or cytologically confirmed tumor diagnosis.
- Receiving neo-adjuvant treatment according to standard care.
You will not qualify if you...
- Behavioral, cognitive, or psychiatric issues affecting study participation.
- Poor venous access.
- Close personal or work relationship with investigators.
- Any medical condition making the investigational drug unsafe or study results unreliable.
- Participation in another interventional clinical study within 30 days.
- Second active malignancy or treatment for one within 1 year, except cured localized basal or squamous cell cancer.
- Significant heart problems including low heart function or abnormal ECG.
- Abnormal vital signs preventing participation.
- Other diseases or lab findings contraindicating study drug use.
- Major surgery unrelated to the tumor within 4 weeks before dosing.
- Recent infections or fever within 7 days before dosing.
- Planned major non-tumor surgery during the study period except emergencies.
- Prior bone marrow or organ transplant.
- History of severe allergic reactions related to study drugs.
- Mild allergies acceptable if not clinically significant.
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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
CONTACT
N
Noortje van Dijk, Msc
CONTACT
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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