Clinical trial · Interventional
Testing a New Imaging Agent to Identify Cancer
Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
NCT04692831CI-TRIAL-00117701active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Positive Malignant Carcinoma of Breast | — | UNRESOLVED | — |
| HER2-positive Metastatic Breast Cancer | — | UNRESOLVED | — |
| HER-2 Protein Overexpression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-ss-pertuzumab PET/CT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HER2-positive malignancy
- description
- Participants will have a diagnosis of HER2-positive malignancy
- interventionNames
- Combination Product: 89Zr-ss-pertuzumab PET/CT
- type
- EXPERIMENTAL
- label
- HER2-low malignancy
- description
- Participants will have a diagnosis of HER2-low malignancy
- interventionNames
- Combination Product: 89Zr-ss-pertuzumab PET/CT
Primary outcomes (1)
- measure
- Evaluate clinical safety of 89Zr-ss-pertuzumab
- timeFrame
- Up to 20 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization \[ISH\]-negative, including FISH. * Biopsy proven primary malignancy or metastatic disease * At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment * Age 18 years or greater * ECOG performance of 0-2 Exclusion Criteria: * Creatinine \> 2 times normal limit (obtained with 8 weeks of enrollment) * AST/ALT \> 2 times normal limit (obtained with 8 weeks of enrollment) * Life expectancy \< 3 months * Pregnancy or lactation * Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
References
Publications (2)
- DERIVEDYeh R, O'Donoghue JA, Jayaprakasam VS, Mauguen A, Min R, Park S, Brockway JP, Bromberg JF, Zhi WI, Robson ME, Sanford R, Modi S, Agnew BJ, Lyashchenko SK, Lewis JS, Ulaner GA, Zeglis BM. First-in-Human Evaluation of Site-Specifically Labeled 89Zr-Pertuzumab in Patients with HER2-Positive Breast Cancer. J Nucl Med. 2024 Mar 1;65(3):386-393. doi: 10.2967/jnumed.123.266392. PMID 38272704
- DERIVEDZeglis BM, Lewis JS. Click Here for Better Chemistry. N Engl J Med. 2022 Dec 15;387(24):2291-2293. doi: 10.1056/NEJMcibr2213596. Epub 2022 Nov 30. No abstract available. PMID 36449446