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- W2247693617 abstract "e14574 Background: Nimotuzumab, a humanized IgG1 monoclonal antibody targeting EGFR, has been used in head & neck cancer or malignant glioma outside Japan, and MTD including severe skin rash were not observed up to 800mg/body. This phase I study of nimotuzumab was conducted to investigate the safety profile, MTD, DLT, PK, human antibody against nimotuzumab (HAHA) in Japanese patients (pts), and PD analysis (activation of EGFR, Akt, MAPK, Ki67) was done. Methods: Pts with advanced solid tumors having no available standard therapy were enrolled. Nimotuzumab was given intravenously at dose levels of nimotumumab 100, 200 and 400mg/body, weekly. Blood, skin samples before treatment and after 4th infusion and pre-treatment tumor were collected for PD analysis. Results: 4 pts were enrolled in each level (total 12 pts). Pt characteristics were M/F 5/7, median age 57 years, ECOG PS 0/1 7/5. No grade 3 or 4 toxicities and no DLT were observed, and MTD was not determined. The major adverse event was grade 1 or 2 skin rash (58%, 7/12). Neither infusion reaction nor HAHA was observed. AUC 0-inf , C max and t 1/2 increased and CL deceased by dose dependent manner, indicating nonlinear PK characteristic. SD and PD were observed in 8 patients (67%) and4 patients (33%), without objective responses. Median time to progression was 4 months. Time to progression seemed to be longer in the pts with amplified gene copy number of EGFR though the number of pts was limited. Conclusions: Weekly infusion of nimotuzumab was well tolerated up to 400 mg/body in Japanese pts. A correlation between anti-tumor activity and EGFR amplification was speculated. Additional PD analysis is currently ongoing. No significant financial relationships to disclose." @default.
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- W2247693617 date "2009-05-20" @default.
- W2247693617 modified "2023-09-22" @default.
- W2247693617 title "Phase I study of nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody in patients with solid tumors in Japan" @default.
- W2247693617 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.e14574" @default.
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