PET [89Zr]DFO-starPEG in Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Flavell, MD, PhD
About this trial
This is a first-in-human, pilot study of the novel PET-imaging radiotracer \[89Zr\]DFO-starPEG. The study is designed to obtain preliminary data to support future development of this agent as an imaging surrogate to visualize enhanced permeability and retention (EPR)-mediated tracer uptake before administration of EPR-based nanomedicines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years.
Histological or cytological confirmation of solid tumor malignancy.
Any malignancy, with at least one soft tissue lesion measurable at 1 centimeter (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, OR at least 1 lesion which is positive (defined as greater than surrounding background) in the bones on standard of care cancer imaging PET exam.
Clinically able to undergo PET/CT imaging.
Disqualifiers
Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia).
Individuals who are pregnant or breastfeeding/chestfeeding. Pregnant and breastfeeding/chestfeeding 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-starPEG. Females of childbearing potential must have a negative pregnancy test before administration of [89Zr]DFO-starPEG, as outlined in inclusion criterion #7. Breastfeeding/chestfeeding should be discontinued before administration of [89Zr]DFO-starPEG.
Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of [89Zr]DFO-starPEG.
A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
Trial design
Design model
Single group
Treatments tested in this trial
89-zr-dfo-star polyethylene glycol (StarPEG)
DrugGiven intravenously (IV)
Whole Body Positron Emission Tomography (PET)
Procedure/SurgeryImaging procedure
Specimen Collection
Procedure/SurgeryUrine and blood specimens will be collected for correlative studies
Treatment groups
13 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Multiple Scans (89Zr]DFO-starPEG)Experimental treatment 3 interventions
Group B: Cohort B: Single Scan (89Zr]DFO-starPEG)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Median Maximum Standardized Uptake Value (SUVmax) by cohort
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.
Time frame
Up to 9 days2
Tumor-to-background signal ratio (muscle)
Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to muscle SUV ratios will be calculated by dividing tumoral SUV by muscle SUV, respectively
Time frame
Up to 9 days3
Tumor-to-background signal ratio (blood)
Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to blood SUV ratios will be calculated by dividing tumoral SUV by blood SUV.
Time frame
Up to 9 days4
Mean absorbed dose of PET [89Zr]DFO-starPEG (Cohort A)
Volumes of interest (VOIs) will be drawn around regions identified on the scans that exhibits clearly elevated uptake over the background. Time-activity curves will be generated for each organ, and curve-fitting will be performed to derive the time-integrated activity coefficients (TIACs, also known as residence times). TIACs will be entered into the OLINDA software. The results from all participants in the dosimetry cohort will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose.
Time frame
Up to 9 daysSecondary outcomes
1
Proportion of participants with treatment-emergent adverse events
Adverse events reported after infusion will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by cohort will be reported.
Time frame
Up to 9 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Robert Flavell, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution
ProLynx LLC
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov