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• W2732853600 abstract "11095 Background: Human epidermal growth factor receptor 3 (HER3) can play a critical role in tumor growth, proliferation and progression. The glycoengineered humanized monoclonal HER3-targeting antibody RG7116 is currently in phase I development (NCT01482377). Knowledge about whole body target expression, drug biodistribution and organ pharmacokinetics is lacking from many phase I designs. The aim of this imaging study is to determine in vivo biodistribution and tumor targeting characteristics of RG7116 by means of immunoPET using 89Zr-RG7116. Methods: Patients with HER3-positive metastatic or locally advanced solid tumors underwent 89Zr-RG7116-PET before treatment with RG7116. To determine optimal tracer dose and imaging schedule patients received 89Zr-RG7116 with increasing doses of unlabeled RG7116 followed by up to 3 PET scans until 7 days post injection (pi). Tracer uptake in organs of interest and tumor lesions was quantified as standardized uptake value (SUV) and tumor-to-background ratios (TBR) were calculated. Results: 13 patients participated without experiencing major safety issues. Initially, 7 patients received 37 MBq 89Zr-RG7116 containing 10, 50 or 100 mg unlabeled RG7116. The optimal dose was 100 mg and PET 2 days pi did not add valuable information. Subsequent patients (n=6) were evaluated at the 100 mg dose with PET scans 4 and 7 days pi. In all 13 patients tracer uptake in tumor lesions was seen, including in 12/13 biopsied HER3-positive lesions. In 3 of the 13 patients previously unknown brain and bone metastases were also detected. At the 100 mg dose 37 tumor lesions (9 patients) were quantifiable, with mean SUVmax 4 days pi of 4.2 (±1.8 SD). Normal antibody tissue distribution was seen with mean SUVmax 4 days pi for liver 8.1, intestine 6.5, blood pool 6.2, kidney 5.0, spleen 4.9, and low uptake in the vertebrae 2.7, lung 1.4, muscle 1.1 and brain 0.5, resulting in mean TBR of 3.60 (range 1.10-9.53). Conclusions: With 89Zr-RG7116-PET biodistribution of RG7116 was determined and tumor specific uptake of 89Zr-RG7116 was shown in patients with HER3-positive metastatic cancer. Analysis of HER3 saturation by repeated 89Zr-RG7116-PET scanning is ongoing. Clinical trial information: NCT01482377." @default.
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• W2732853600 date "2014-05-20" @default.
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• W2732853600 title "Phase I imaging study of the HER3 antibody RG7116 using ⁸⁹Zr-RG7116-PET in patients with metastatic or locally advanced HER3-positive solid tumors." @default.
• W2732853600 doi "https://doi.org/10.1200/jco.2014.32.15_suppl.11095" @default.
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