NCT05245006Active, not recruitingPhase 1
PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer
A First-in-Human, Pilot PET Imaging Study of 89Zr-DFO-YS5, an immunoPET Agent for Detecting CD46 Positive Malignancy in Men With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 8 Feb 2022
- Start date
- 18 Mar 2022
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Robert Flavell, MD, PhD
- Diseases
- Prostate cancer
- NCT number
- NCT05245006
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 18 Mar 2022 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
Age
- Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent.
Who the study is looking for
- Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
- Age \>=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%).
- Demonstrates adequate organ function as defined below:
- Total bilirubin \<1.5 X upper limit of normal (ULN).
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \<= 3 X institutional upper limit of normal (ULN).
- Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \<= 3 X institutional ULN.
- Serum creatinine \<=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) \>= 60 mL/min, calculated using the Cockcroft-Gault equation.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.