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New treatment option for Solid Tumor
Official title PET-imaging of Two Vartumabs in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06645808
What this study is testing
What is 89Zr-DFO-N-Suc-F8scFv?
89Zr-DFO-N-Suc-F8scFv is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study...
- Patients aged ≥ 18 years at moment of signing informed consent form.
- Life expectancy of \> 12 weeks.
You likely can't join if
- Behavioral or cognitive impairment or psychiatric disease that, in the investigator's opinion, affects the patient's ability to understand and...
- Insufficient venous access for the study procedures.
- Close affiliation with the investigator, e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the...
- Any finding in the medical examinations or medical history giving, in the opinion of the investigator, reasonable suspicion of a disease or condition...
- Participation in an treatment clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins...
- 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...
See the full eligibility criteria
Who can join
- General
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- 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...
- Patients aged ≥ 18 years at moment of signing informed consent form.
- Life expectancy of \> 12 weeks.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- BMI ≥ 18.0 and ≤ 35.0 kg/m2 and weight at least 50 kg and no more than 120 kg at screening.
- 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.
- 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...
- eGFR (based on plasma-creatinine) = \>30 mL/min.
- Serum albumin \>35 g/L.
- No other clinically significant laboratory abnormalities as determined by the investigator. Note: one retest of lab tests is allowed within the screening window.
- 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...
- Male people 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...
- Patients diagnosed with colon carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
- Histologically confirmed diagnosis of colon carcinoma.
- Neo-adjuvant treatment according to the standard of care. Rectal Carcinoma:
- Patients diagnosed with rectal carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
- Histologically confirmed diagnosis of rectal carcinoma.
- Neo-adjuvant treatment according to the standard of care. Bone- and soft-tissue sarcoma
- Patients diagnosed with a bone- or soft-tissue sarcoma stage I-IV, according to AJCC staging for Sarcoma.
- Histologically confirmed diagnosis of sarcoma.
- Neo-adjuvant treatment according to the standard of care. Breast carcinoma
- Patients diagnosed with breast carcinoma stage I-IV, according to the 8th edition of the TNM-classification.
- Histologically confirmed diagnosis of breast carcinoma.
- Neo-adjuvant treatment according to the standard of care. Lung Carcinoma:
- 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.
- Neo-adjuvant treatment according to the standard of care. Head and Neck Squamous Cell carcinoma (HNSCC):
- Patients diagnosed with HNSCC of the oral cavity, oropharynx, nasal cavity, nasopharynx, hypopharynx and larynx.
- Histologically confirmed diagnosis of HNSCC.
- Neo-adjuvant treatment according to the standard of care. Oesophageal and gastric carcinoma:
- Patients diagnosed with oesophagus carcinoma stage I-IV according to the 7th edition of the TNM-classification.
- Patients diagnosed with gastric carcinoma stage I-IV according to the 7th edition of the TNM-classification.
- Histologically confirmed diagnosis of oesophageal- or gastric carcinoma.
- Neo-adjuvant treatment according to the standard of care. Pancreas carcinoma:
- 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.
- Histologically or cytologically confirmed diagnosis of pancreas carcinoma.
- Neo-adjuvant treatment according to the standard of care. Bladder carcinoma:
- Patients diagnosed with invasive bladder carcinoma stage I-IV according to the 7th edition of the TNM-classification.
- Histologically confirmed diagnosis of bladder carcinoma.
- Neo-adjuvant treatment according to the standard of care. Glioblastoma:
- 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.
- Karnofsky performance status of at least 70%.
- Neo-adjuvant treatment according to the standard of care. General
What rules you out
- Behavioral or cognitive impairment or psychiatric disease that, in the investigator's opinion, affects the patient's ability to understand and cooperate with the study protocol.
- Insufficient venous access for the study procedures.
- 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...
- 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...
- Participation in an treatment clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device. Medical Exclusion Criteria:
- 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...
- Cardiac impairment with an estimated LVEF \ 450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.
- 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.
- 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...
- 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.
- 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.
- 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.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Provincie Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Provincie Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.