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CCR2 PET Imaging in HNSCC
NCT07659678Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2026
- Primary completion
- May 2032
- Countries
- 1
- Sponsor
- Washington University School of Medicine
- Drugs
- Cu-DOTA-ECL1i
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label trial of Cu-DOTA-ECL1i in head and neck squamous cell carcinoma (HNSCC) (2 cohorts), sponsored by Washington University School of Medicine. Primary endpoints: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake at 1 day, Quantitative 64Cu-DOTA-ECL1i PET/CT uptake at 14 days and 5 more. Started Oct 2026; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort 1: Newly Diagnosed HNSCC
Newly Diagnosed HNSCC scheduled to undergo surgical resection
Cohort 2: Recurrent/metastatic HNSCC
Recurrent/metastatic HNSCC candidates for first-line anti-PD1 therapy
03
Who it enrols
Adults with newly diagnosed locally advanced or recurrent/metastatic HNSCC scheduled for surgery or first-line anti-PD1 therapy, with lesion size >= 1.0 cm. Excludes pregnant/nursing women and those with other recent invasive malignancies.
04
Endpoints
Primary
Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
CCR2 expression in tumor tissue
Change in 64Cu-DOTA-ECL1i PET uptake from baseline to post-cycle 3 imaging
Objective response
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