Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-DFO-YS5 | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | Procedure | — | UNRESOLVED |
| Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) | Procedure | — | UNRESOLVED |
| YS5 antibody | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: 89Zr-DFO-YS5
- description
- Participants receive one dose of 89Zr-DFO-YS5 up to 3 millicurie (mCi), and undergo a whole body PET performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. The optimized scan time will be used for imaging in cohorts B and C. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
- interventionNames
- Drug: 89Zr-DFO-YS5
- Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)
- Procedure: Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
- type
- EXPERIMENTAL
- label
- Cohort B: 89Zr-DFO-YS5, YS5 antibody
- description
- Participants receive either a 20mg or 50mg dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. The optimal dose of unmodified YS5 antibody will be used in the following cohorts C \& D. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC). 2. Age \>=18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%). 4. Demonstrates adequate organ function as defined below: 1. Total bilirubin \<1.5 X upper limit of normal (ULN). 2. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \<= 3 X institutional upper limit of normal (ULN). 3. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \<= 3 X institutional ULN. 4. Serum creatinine \<=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) \>= 60 mL/min, calculated using the Cockcroft-Gault equation. 5. Ability to understand a written informed consent document, and the willingness to sign it. 6. 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. Exclusion Criteria: 1. Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
References
Publications (0)
Data not yet available