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

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

Sponsors and collaborators

Robert Flavell, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

ProLynx LLC

Collaborator

National Cancer Institute (NCI)

Collaborator