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CCR2 PET imaging head and neck squamous cell carcinoma

Award Number: R01CA311526
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/05/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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CCR2 PET imaging head and neck squamous cell carcinoma - Approximately two-thirds newly diagnosed head & neck squamous cell carcinoma (HNSCC) patients present with advanced-stage disease, usually with regional lymph node (LN) involvement. Up to 60% of patients with advanced stage HNSCC develop disease recurrence after standard treatment; the median overall survival (OS) for recurrent/metastatic (R/M) patients is ~ 1 year. Despite the routine use of immune checkpoint inhibitors (ICI) in the R/M setting, response rates are poor further compounding the obstacles in HNSCC treatment. There is an unmet clinical need for the development of imaging agents as biomarkers for accurate prediction of prognosis and appropriate therapy selection. A molecular biomarker in HNSCC, C-C motif chemokine receptor 2 (CCR2) is of particular interest due to its specific and elevated expression on squamous cells and tumor associated macrophages (TAMs) and its role in promoting the recruitment of TAMs in the process of tumor invasion and metastasis. The levels of CCR2 expression correlated to shorter OS and disease-free survival (DFS) in cancer patients, and postoperative survival and recurrence of some patients with non-metastatic cancers, suggesting the prognostic potential of CCR2. We have developed a radiotracer 64Cu-DOTA-ECL1i to image and quantify in vivo CCR2+ cells using positron emission tomography (PET). In HNSCC patients (eIND# 137620), 64Cu-DOTA- ECL1i PET/CT revealed uptake in primary tumors and regional LN metastasis. Histopathological characterization of patients’ surgical specimens showed high and specific expression of CCR2 mainly on tumor cells and CD68+ TAMs. Our preclinical data showed that CCR2-PET could sensitively detect treatment response to anti-PD1 therapy, supporting CCR2 as a potential prognostic biomarker for HNSCC. These data support our hypothesis that our radiotracer can measure CCR2 expression, serve as a determinant of tumor activity, and have the potential for predicting HNSCC prognosis. Aim 1. Assess the imaging characteristics of 64Cu-DOTA-ECL1i PET for primary tumor and LN metastasis in treatment-naïve, locally advanced (LA)-HNSCC patients.1A. Quantify the imaging characteristics of 64Cu-DOTA-ECL1i in primary tumors and LN metastases in LA-HNSCC patients undergoing surgery with clinically identified locoregional LN metastasis. 1B. Characterize CCR2 expression and correlation with 64Cu-DOTA-ECL1i uptake, identify associated cell types, immune cell composition, tumor type/stage, extent of nodal metastasis, TAM invasion, human papillomavirus (HPV)/p16 status and radiotracer binding specificity in the resected specimens. Aim 2: Assess 64Cu-DOTA-ECL1i PET in phenotyping patients, monitoring treatment response, and predicting the long-term clinical outcomes in R/M-HNSCC patients receiving ICI therapy. 2A. Assess the efficiency of 64Cu-DOTA-ECL1i PET in R/M-HNSCC patients before and after receiving anti-PD1 therapy to determine the relationship between tracer uptake and treatment response. 2B. Perform multivariate analyses adjusted for all significant descriptive, univariate variables to define the hazard ratio of CCR2 PET imaging and determine its independent prognostic effect on DFS and OS.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $637,394 )
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Cancer Detection and Diagnosis Research	000	1	8/5/2026	NEW	$637,394
														Subtotal = $637,394

Grand Total All Awards = $637,394

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CCR2 PET imaging head and neck squamous cell carcinoma

Award Number: R01CA311526

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/05/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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