Clinical trial · Interventional
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic 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)
This is a Phase I/IIa study evaluating the safety and feasibility of \[89Zr\]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of \[89Zr\]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of \[89Zr\]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.
Conditions
Conditions (1)
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 Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [89Zr]Df-IAB2M | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [89Zr]Df-IAB2M
- description
- A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).
- interventionNames
- Biological: [89Zr]Df-IAB2M
Primary outcomes (1)
- measure
- Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
- timeFrame
- Day 1 (Infusion Day) through Day 7
- description
- To assess the safety of a single dose of of \[89Zr\]Df-IAB2M
Secondary outcomes (3)
- measure
- [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
- timeFrame
- Day 1 (Infusion Day) to Day 3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult male \>/= 18 years of age * Patients with histologically confirmed prostate cancer * Progressive disease manifest (within 6 weeks of screening) by either * imaging modalities (bone scan, MRI or CT) OR * biochemical progression (PSA) * Performance status of 60 or higher on Karnofsky scale * Subject's schedule permits compliance with all study procedures * Ability to understand and willingness to sign a written informed consent form Exclusion Criteria: * Previous anaphylactic reaction to huJ591 antibody or FDG imaging * On any new anticancer therapy (GnRH analog allowed) while on the study * Hepatic lab values: Bilirubin\>1.5 ULN; AST/ALT \>2.5 ULN; Albumin \< 2 g/dL; GGT \> 2.5 ULN if Alkaline Phostphatase \>2.5 ULN * Renal lab values: Creatinine \> 1.5 ULN * Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
References
Publications (0)
Data not yet available