This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.
Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.
At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.
Clinically able to undergo PET-CT imaging or PET-MRI.
Age ≥ 18 years.
Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.
Individuals who are pregnant or breastfeeding/chest-feeding. Pregnant and breastfeeding/chest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with [89Zr]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of [89Zr]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding/chest-feeding should be discontinued before administration of [89Zr]DFO-YS5.
Hypersensitivity to [89Zr]DFO-YS5 or any of its excipients.
Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.
Single group
[89Zr]DFO-YS5
DrugGiven intravenously (IV)
Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI)
Procedure/SurgeryParticipants may receive a whole-body PET-MRI or a whole body PET-CT
Positron Emission Tomography (PET)-Computerized tomography (CT)
Procedure/SurgeryParticipants may receive a whole-body PET-CT or a whole-body PET-MRI
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan
A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.
Median intra-tumoral SUVmax
The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
Tumor-to-background signal (Ratio)
The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ
Proportion of participants with reported treatment-emergent adverse events
The proportion of participants with reported treatment-emergent Adverse events (AEs) will be classified and graded according to the NCI CTCAE version. 5.0 by severity and type evaluated from the time of administration through the Day 6-8 Visit (120-168 hours post-dose).
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Robert Flavell, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution
Kyntra Bio
Collaborator
Fortis Therapeutics, Inc.
Collaborator
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