PET [89Zr]DFO-starPEG in Solid Tumors

NCT06894745 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 259211R01CA266666-01A1NCI-2025-02151
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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 EPR-based nanomedicines.

Conditions

Solid Tumor; Solid Carcinoma; Soft Tissue Lesion

Keywords

Dosimetry; Imaging

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Up to 9 days

Secondary Outcomes (1)

• Proportion of participants with treatment-emergent adverse events

  Up to 9 days

Study Arms (2)

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).

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.

Drug: 89-zr-dfo-star polyethylene glycol (StarPEG); Procedure: Whole Body Positron Emission Tomography (PET); Procedure: Specimen Collection

Interventions

89-zr-dfo-star polyethylene glycol (StarPEG) DRUG

Given intravenously (IV)

Also known as: [89Zr]DFO-starPEG

Cohort A: Multiple Scans (89Zr]DFO-starPEG); Cohort B: Single Scan (89Zr]DFO-starPEG)

Whole Body Positron Emission Tomography (PET) PROCEDURE

Imaging procedure

Also known as: Whole Body PET Scan, Whole Body PET

Cohort A: Multiple Scans (89Zr]DFO-starPEG); Cohort B: Single Scan (89Zr]DFO-starPEG)

Specimen Collection PROCEDURE

Urine and blood specimens will be collected for correlative studies

Also known as: Biospecimen Collection

Cohort A: Multiple Scans (89Zr]DFO-starPEG); Cohort B: Single Scan (89Zr]DFO-starPEG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmation of solid tumor malignancy.
• Any solid tumor 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.
• Clinically able to undergo PET/CT imaging.
• Age \>= 18 years.
• 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:
• 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.

You may not qualify if:

• Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia).
• 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.

Sponsors & Collaborators

• Robert Flavell, MD, PhD: lead
• ProLynx LLC: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Robert Flavell, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

(415) 514-8987; Maya.Aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Residence

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)