PET-imaging of Two Vartumabs in Patients With Solid Tumors
NCT ID: NCT06645808
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
32 participants
INTERVENTIONAL
2024-12-10
2026-09-30
Brief Summary
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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.
Detailed Description
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VAR2 Pharmaceuticals has identified and characterized oncofetal CS as a group of tumor-specific carbohydrate motifs that appear in placental tissue during fetal development and in most cancers while remaining largely absent from healthy tissue. VAR2 Pharmaceuticals recently developed a panel of antibodies specific for oncofetal CS and characterized their tumor specificity, therapeutic, and safety in pre-clinical models under various formats.
VARTUTRACE is a Phase 0 microdosing study of a single administration of \<30 nmol of one of the two most promising antibody fragments identified by VAR2 Pharmaceuticals - C9 and F8. Both antibody fragments will be used as short chain variable fragments (scFvs) labelled with the radioisotope Zirconium-89 (89Zr) and are therefore respectively named 89Zr-C9scFv or 89Zr-F8scFv. As it remains unclear from the pre-clinical in vitro and in vivo data which of the two will have the most optimal tumor targeting properties in patients with solid tumors, both scFvs will be evaluated.
The biodistribution, pharmacokinetics, pharmacodynamics, and clearance of two of these antibody fragments is planned to be studied in up to 32 patients with various cancers (i.e. a basket-trial).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
After the interim analysis, cohorts will be expanded with additional solid tumor indications and will include 13 more subjects per compound (n=26), resulting in 32 subjects overall. This basket trial aims to include at least one patient per indication.
For expansion cohort subjects, IMP-administration will occur on day 1, with one PET/CT scan performed on the most optimal day (this was determined to be day 4). Optionally, patients can receive an additional day 6 scan to gain more insight into tumor retention.
OTHER
NONE
Study Groups
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89Zr-F8scFv
The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-F8scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose.
The following 13 patients will receive a single i.v. microdose administration of 89Zr-F8scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.
89Zr-DFO-N-Suc-F8scFv
89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.
PET/CT scan
IMP administration will be followed by PET/CT scans on day 1, 2 and 4.
89Zr-C9scFv
The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-C9scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose.
The following 13 patients will receive a single i.v. microdose administration of 89Zr-C9scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.
89Zr-DFO-N-Suc-C9scFv
89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.
PET/CT scan
IMP administration will be followed by PET/CT scans on day 1, 2 and 4.
Interventions
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89Zr-DFO-N-Suc-F8scFv
89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.
89Zr-DFO-N-Suc-C9scFv
89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.
PET/CT scan
IMP administration will be followed by PET/CT scans on day 1, 2 and 4.
Eligibility Criteria
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Inclusion Criteria
2. Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
3. Patients aged ≥ 18 years at moment of signing informed consent form.
4. Life expectancy of \> 12 weeks.
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
6. BMI ≥ 18.0 and ≤ 35.0 kg/m2 and weight at least 50 kg and no more than 120 kg at screening.
7. Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator. Note: one retest of vital functions and ECG is allowed within the screening window.
8. Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit:
* AST, ALT, and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN) as determined by the UMCG laboratory reference values.
* Serum bilirubin ≤ 2.0x ULN as determined by the UMCG laboratory reference values. Patients with known Gilbert disease who have serum bilirubin level ≤ 3x ULN may be enrolled.
* INR or APTT ≤ 1.5x ULN as determined by the UMCG laboratory reference values. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
* eGFR (based on plasma-creatinine) = \>30 mL/min.
* Serum albumin \>35 g/L.
9. No other clinically significant laboratory abnormalities as determined by the investigator. Note: one retest of lab tests is allowed within the screening window.
10. Female patients should be at least 1 year post-menopausal (amenorrhea \>12 months and/or follicle-stimulating hormone \>30 mIU/mL) at screening or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation).
11. Male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control, and must not donate sperm, until 3 months after administration of 89Zr-DFO-N-Suc-scFv (F8 or C9).
Colon Carcinoma:
1. Patients diagnosed with colon carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
2. Histologically confirmed diagnosis of colon carcinoma.
3. Neo-adjuvant treatment according to the standard of care.
Rectal Carcinoma:
1. Patients diagnosed with rectal carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
2. Histologically confirmed diagnosis of rectal carcinoma.
3. Neo-adjuvant treatment according to the standard of care.
Bone- and soft-tissue sarcoma
1. Patients diagnosed with a bone- or soft-tissue sarcoma stage I-IV, according to AJCC staging for Sarcoma.
2. Histologically confirmed diagnosis of sarcoma.
3. Neo-adjuvant treatment according to the standard of care.
Breast carcinoma
1. Patients diagnosed with breast carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
2. Histologically confirmed diagnosis of breast carcinoma.
3. Neo-adjuvant treatment according to the standard of care.
Lung Carcinoma:
1. Anticipated diagnosis of Non-Small Cell Lung Carcinoma (NSCLC) stage I-IV, according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)/CT or based on cytology.
2. Neo-adjuvant treatment according to the standard of care.
Head and Neck Squamous Cell carcinoma (HNSCC):
1. Patients diagnosed with HNSCC of the oral cavity, oropharynx, nasal cavity, nasopharynx, hypopharynx and larynx.
2. Histologically confirmed diagnosis of HNSCC.
3. Neo-adjuvant treatment according to the standard of care.
Oesophageal and gastric carcinoma:
1. Patients diagnosed with oesophagus carcinoma stage I-IV according to the 7th edition of the TNM-classification.
2. Patients diagnosed with gastric carcinoma stage I-IV according to the 7th edition of the TNM-classification.
3. Histologically confirmed diagnosis of oesophageal- or gastric carcinoma.
4. Neo-adjuvant treatment according to the standard of care.
Pancreas carcinoma:
1. Anticipated diagnosis of pancreas carcinoma stage I-IV according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)/CT or based on cytology.
2. Histologically or cytologically confirmed diagnosis of pancreas carcinoma.
3. Neo-adjuvant treatment according to the standard of care.
Bladder carcinoma:
1. Patients diagnosed with invasive bladder carcinoma stage I-IV according to the 7th edition of the TNM-classification.
2. Histologically confirmed diagnosis of bladder carcinoma.
3. Neo-adjuvant treatment according to the standard of care.
Glioblastoma:
1. Anticipated diagnosis of a high-grade glioma (glioblastoma, grade 4 according to the WHO classification) based on imaging modalities such as MRI and/or CT or a biopsy.
2. Karnofsky performance status of at least 70%.
3. Neo-adjuvant treatment according to the standard of care.
Exclusion Criteria
2. Insufficient venous access for the study procedures.
3. Close affiliation with the investigator, e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of surgery or nuclear department of the UMCG,TRACER or affiliates.
4. Any finding in the medical examinations or medical history giving, in the opinion of the investigator, reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications.
5. Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device.
1. The existence of a second concomitant active malignancy or treatment for a second malignancy within 1 year prior to IMP-administration that is not a solid tumor indication included in the VARTUTRACE study, except for localized basal or squamous cell cancer that has been cured at least 90 days before screening.
2. Cardiac impairment with an estimated LVEF \<35 % Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.
3. Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate. Note: One retest of vital functions is allowed within the screening window.
4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
5. Major surgical procedure other than for the included diagnosis within four weeks before IMP administration. Disease-related procedures, e.g. the placement of a port-a-cath, placement of a drain, ERCP, are allowed.
6. Current evidence or history of bacterial, viral or fungal infections within 7 days before 89Zr-DFON-Suc-scFv (F8 or C9) administration as judged by the Investigator.
* T \> 38.0°C or lab confirmed viral/bacterial/fungal infection (PCR) or symptoms suggestive of an infection)
* Received oral or IV antibiotics within \<7 days before administration.
7. Any planned major surgery within the duration of the study (until follow-up visit) that is not related to the tumor, with the exception of any emergency surgeries.
8. Prior allogeneic bone marrow transplantation or solid organ transplant.
9. A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angio-edema or treatment need can be acceptable if deemed not of clinical significance (including allergy to animals or mild seasonal hay fever).
10. Any other diseases, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
18 Years
ALL
No
Sponsors
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TRACER Europe BV
INDUSTRY
Var2 Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gooitzen van Dam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
TRACER Europe B.V.
Locations
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University Medical Center Groningen (UMCG)
Groningen, Provincie Groningen, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Anne-Fleur Verhaar, MD
Role: primary
Noortje van Dijk, Msc
Role: backup
Other Identifiers
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2024-513827-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
VAR2-2024-CS01
Identifier Type: -
Identifier Source: org_study_id