Solid TumorPhase 1NCT06894745
PET [89Zr]DFO-starPEG in Solid Tumors
A Phase 1 study testing 89-zr-dfo-star polyethylene glycol (StarPEG), Whole Body Positron Emission Tomography (PET) and Specimen Collection in people with Solid Tumor and Solid Carcinoma, run by Robert Flavell, MD, PhD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Carcinoma, Soft Tissue Lesion
- What is being tested?
- 89-zr-dfo-star polyethylene glycol (StarPEG), Whole Body Positron Emission Tomography (PET) and Specimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50%.
- Adequate organ function as defined below within 0-28 days before [89Zr]DFO-starPEG administration:
Show all 13Show fewer
- Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits) .
- Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 x ULN.
- Alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x ULN.
- Estimated creatinine clearance: ≥ 60 mL/min, calculated using the Cockcroft-Gault equation or 24 hour urine collection.
- Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before 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). The result of the urine or serum pregnancy test must be negative in order to initiate the [89Zr]DFO-starPEG administration. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with [89Zr]DFO-starPEG.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
- Individuals who do not agree to follow the below contraception requirements:
- 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).
- Hypersensitivity to [89Zr]DFO-starPEG 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Maya Alsam, (415) 514-8987, maya.aslam@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To descriptively report patterns of [89Zr]DFO-starPEG uptake on whole-body PET (Cohorts A \& B).
II. To determine the radiation dosimetry following [89Zr]DFO-starPEG administration (Cohort A).
SECONDARY OBJECTIVES:
- To determine the safety of [89Zr]DFO-starPEG (Cohorts A \& B).
EXPLORATORY OBJECTIVES:
- To study the pharmacokinetics of [89Zr]DFO-starPEG and estimate its half-life (Cohort A).
OUTLINE:
Participants will be assigned to one of 2 cohorts:
- COHORT A: Participants will receive multiple scans over time
- COHORT B: Participants will receive a scan at a single time point
Participants will be followed for adverse events for approximately 1 week after radiotracer administration until the Day 5-9 visit.
- Conditions
- Solid Tumor, Solid Carcinoma, Soft Tissue Lesion
- Being tested
- 89-zr-dfo-star polyethylene glycol (StarPEG), Whole Body Positron Emission Tomography (PET), Specimen Collection
- Keywords
- Dosimetry, Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89-zr-dfo-star polyethylene glycol (StarPEG)Drug
Also called [89Zr]DFO-starPEG
Given intravenously (IV)
Whole Body Positron Emission Tomography (PET)Procedure or surgery
Also called Whole Body PET Scan, Whole Body PET
Imaging procedure
Specimen CollectionProcedure or surgery
Also called Biospecimen Collection
Urine and blood specimens will be collected for correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Multiple Scans (89Zr]DFO-starPEG) | Experimental | Participants will be administered a single, intravenous microdose (1 - 2 millicurie (mCi) of [89Zr]DFO-starPEG, followed by whole-body positron emission tomography (PET) imaging. PET imaging will be conducted at the following times after [89Zr]DFO-starPEG administration:
2 hours (±30 min), 24 (±4) hours (1 day), 48-72 hours (2-3 days), and 120-216 hours (5-9 days). Receives: Drug: 89-zr-dfo-star polyethylene glycol (StarPEG); Procedure: Whole Body Positron Emission Tomography (PET); Procedure: Specimen Collection |
| Cohort B: Single Scan (89Zr]DFO-starPEG) | Experimental | Participants will be administered a single, intravenous microdose (1 - 2 mCi) of [89Zr]DFO-starPEG, followed by whole-body PET imaging will be conducted 120-216 hours (5-9 days) after [89Zr]DFO-starPEG administration. Receives: Drug: 89-zr-dfo-star polyethylene glycol (StarPEG); Procedure: Whole Body Positron Emission Tomography (PET); Procedure: Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 9 days
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
Measured: Up to 9 days
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.
Measured: Up to 9 days
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.
Measured: Up to 9 days
Secondary 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.
Measured: Up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Flavell, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- ProLynx LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Robert Flavell, MD, PhD, University of California, San Francisco
- Investigators
- Robert Flavell, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894745
- Sponsor's protocol ID
- 25921
- Other IDs
- 1R01CA266666-01A1, NCI-2025-02151
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06894745
- Acronym / sponsor ID
- 25921
- Conditions
- Solid Tumor, Solid Carcinoma, Soft Tissue Lesion
- Keywords
- Dosimetry, Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Robert Flavell, MD, PhDUniversity, hospital or other
- Collaborators
- ProLynx LLC, National Cancer Institute (NCI)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To descriptively report patterns of [89Zr]DFO-starPEG uptake on whole-body PET (Cohorts A \& B).
II. To determine the radiation dosimetry following [89Zr]DFO-starPEG administration (Cohort A).
SECONDARY OBJECTIVES:
- To determine the safety of [89Zr]DFO-starPEG (Cohorts A \& B).
EXPLORATORY OBJECTIVES:
- To study the pharmacokinetics of [89Zr]DFO-starPEG and estimate its half-life (Cohort A).
OUTLINE:
Participants will be assigned to one of 2 cohorts:
- COHORT A: Participants will receive multiple scans over time
- COHORT B: Participants will receive a scan at a single time point
Participants will be followed for adverse events for approximately 1 week after radiotracer administration until the Day 5-9 visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Multiple Scans (89Zr]DFO-starPEG) | Experimental | Drug: 89-zr-dfo-star polyethylene glycol (StarPEG), Procedure: Whole Body Positron Emission Tomography (PET), Procedure: Specimen CollectionParticipants will be administered a single, intravenous microdose (1 - 2 millicurie (mCi) of [89Zr]DFO-starPEG, followed by whole-body positron emission tomography (PET) imaging. PET imaging will be conducted at the following times after [89Zr]DFO-starPEG administration: 2 hours (±30 min), 24 (±4) hours (1 day), 48-72 hours (2-3 days), and 120-216 hours (5-9 days). |
| Cohort B: Single Scan (89Zr]DFO-starPEG) | Experimental | Drug: 89-zr-dfo-star polyethylene glycol (StarPEG), Procedure: Whole Body Positron Emission Tomography (PET), Procedure: Specimen CollectionParticipants will be administered a single, intravenous microdose (1 - 2 mCi) of [89Zr]DFO-starPEG, followed by whole-body PET imaging will be conducted 120-216 hours (5-9 days) after [89Zr]DFO-starPEG administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50%.
Key exclusion criteria (7 listed)
- 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.
- Individuals who do not agree to follow the below contraception requirements:
- Hypersensitivity to [89Zr]DFO-starPEG 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89-zr-dfo-star polyethylene glycol (StarPEG)Also: [89Zr]DFO-starPEGGiven intravenously (IV) | Drug | Cohort A: Multiple Scans (89Zr]DFO-starPEG), Cohort B: Single Scan (89Zr]DFO-starPEG) |
| Whole Body Positron Emission Tomography (PET)Also: Whole Body PET Scan, Whole Body PETImaging procedure | Procedure or surgery | Cohort A: Multiple Scans (89Zr]DFO-starPEG), Cohort B: Single Scan (89Zr]DFO-starPEG) |
| Specimen CollectionAlso: Biospecimen CollectionUrine and blood specimens will be collected for correlative studies | Procedure or surgery | Cohort A: Multiple Scans (89Zr]DFO-starPEG), Cohort B: Single Scan (89Zr]DFO-starPEG) |
Primary outcome
Median Maximum Standardized Uptake Value (SUVmax) by cohort
Time frame: Up to 9 days
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 (muscle)
Time frame: Up to 9 days
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
Tumor-to-background signal ratio (blood)
Time frame: Up to 9 days
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.
Mean absorbed dose of PET [89Zr]DFO-starPEG (Cohort A)
Time frame: Up to 9 days
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.
1 secondary outcome
Proportion of participants with treatment-emergent adverse events
Time frame: Up to 9 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Flavell, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89-zr-dfo-star polyethylene glycol (StarPEG), Whole Body Positron Emission Tomography (PET) and Specimen Collection in people with Solid Tumor and Solid Carcinoma, run by Robert Flavell, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam ((415) 514-8987, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Maximum Standardized Uptake Value (SUVmax) by cohort (time frame: Up to 9 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.