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PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer

NCT05245006 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-17

No results posted yet for this study

Summary

CD46 is an exciting new therapeutic target in prostate cancer, with the antibody drug conjugate FOR46 under investigation in phase I clinical trials. The hypothesis of the study is that CD46 expression, measured via our novel imaging biomarker, is a characteristic feature of mCRPC, and particularly common in the most lethal forms of the disease including adenocarcinoma and Small-cell neuroendocrine carcinoma (SCNC). These data will provide crucial information about the feasibility of targeting cluster of differentiation 46 (CD46) in mCRPC, will be used guide the development of novel therapeutic and theranostic agents, to help develop treatments that improve outcomes for men with the most lethal forms of prostate cancer.

Conditions

Interventions

DRUG

89Zr-DFO-YS5

3 mCi will be administered intravenously

BIOLOGICAL

YS5 antibody

20 or 50 mg administered intravenously

PROCEDURE

Positron Emission Tomography (PET)/Computerized tomography (CT)

Imaging which combines a CT scan and a PET scan

PROCEDURE

Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)

Imaging which combines an MRI scan and a PET scan

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Fortis Therapeutics, Inc.

    collaborator INDUSTRY

  • Robert Flavell, MD, PhD

    lead OTHER

Principal Investigators

  • Robert Flavell, MD, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245006 on ClinicalTrials.gov