Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • 89-zr-dfo-star polyethylene glycol (StarPEG)
  • Whole Body Positron Emission Tomography (PET)
  • Specimen Collection

Treatment groups

13 Participants
are divided into 2 treatment groups

Locations

1
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

Robert Flavell, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

ProLynx LLC

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov