We are analyzing https://link.springer.com/article/10.1007/s10637-007-9077-0.

Title:
Phase I and pharmacokinetic study of etaracizumab (Abegrin™), a humanized monoclonal antibody against αvβ3 integrin receptor, in patients with advanced solid tumors | Investigational New Drugs
Description:
This study assessed the safety, immunogenicity, and pharmacokinetics of etaracizumab, a monoclonal antibody directed against the αvβ3 integrin, in patients with advanced malignancies. Four cohorts of four patients received escalating dose of etaracizumab as a 30-min intravenous infusion, first as a single test dose, followed-up 2–5 weeks later by weekly doses. Sixteen patients with advanced solid tumors received a total of 309 cycles of etaracizumab at doses ranging 1–6 mg/kg. The mean number of weekly infusions was 19 (ranging 5–53). Frequently reported adverse events were grades 1–2 asthenia (15 patients) and infusion reactions (9 patients). At 1 mg/kg, one patient experienced grade 3 chills with the first infusion. Other grade 3 toxicities included reversible hyponatremia, hypophosphatemia and hyponatremia in one patient each at 1, 4 and 6 mg/kg, respectively. No patient experienced treatment delay/discontinuation due to an adverse event. The half-life of etaracizumab ranged 49–180 h with a nonlinear increase in terminal half-life with increasing doses. There was no objective response but five patients experienced a stable disease of >6-month duration. Etaracizumab was well-tolerated at doses up to 6 mg/kg with no evidence of immunogenicity. The safety profile of etaracizumab warrants further exploration in ongoing phase I/II trials.
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Topics {✒️}

month download article/chapter advanced solid tumors world health organization targeted antiangiogenic therapy open-label study evaluating vegf/vegf-receptor pathway saint-louis university hospital luz hammershaimb karen kaucic human alphavbeta3 integrin+dacarbazine human endothelial cells endothelial cell activation αvβ3 integrin receptor beaujon university hospital monoclonal antibody directed monoclonal antibody specific humanized monoclonal antibody full article pdf solid tumors vascular integrin αvβ3 privacy choices/manage cookies ovarian epithelial tumors human breast cancer related subjects /ii trials progression-related expression renal cell carcinoma doses ranging 1–6 mg/kg human melanoma tumorigenicity single test dose tryrosine phosphorylation events cell adhesion sandrine faivre prostate cancer progression article investigational european economic area antiangiogenic therapy stetler-stevenson wg dimensional dermal collagen felding-habermann dynamic flow conditions angiogenic blood vessels vitro affinity maturation conditions privacy policy monoclonal antibody study evaluating cixutumumab check access instant access beta3 integrin agents /beta-5 integrin distribution

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      headline:Phase I and pharmacokinetic study of etaracizumab (Abegrin™), a humanized monoclonal antibody against αvβ3 integrin receptor, in patients with advanced solid tumors
      description:This study assessed the safety, immunogenicity, and pharmacokinetics of etaracizumab, a monoclonal antibody directed against the αvβ3 integrin, in patients with advanced malignancies. Four cohorts of four patients received escalating dose of etaracizumab as a 30-min intravenous infusion, first as a single test dose, followed-up 2–5 weeks later by weekly doses. Sixteen patients with advanced solid tumors received a total of 309 cycles of etaracizumab at doses ranging 1–6 mg/kg. The mean number of weekly infusions was 19 (ranging 5–53). Frequently reported adverse events were grades 1–2 asthenia (15 patients) and infusion reactions (9 patients). At 1 mg/kg, one patient experienced grade 3 chills with the first infusion. Other grade 3 toxicities included reversible hyponatremia, hypophosphatemia and hyponatremia in one patient each at 1, 4 and 6 mg/kg, respectively. No patient experienced treatment delay/discontinuation due to an adverse event. The half-life of etaracizumab ranged 49–180 h with a nonlinear increase in terminal half-life with increasing doses. There was no objective response but five patients experienced a stable disease of >6-month duration. Etaracizumab was well-tolerated at doses up to 6 mg/kg with no evidence of immunogenicity. The safety profile of etaracizumab warrants further exploration in ongoing phase I/II trials.
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      dateModified:2007-09-18T00:00:00Z
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         Advanced solid tumors
         Endothelial cell adhesion
         Vitaxin
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         Pharmacology/Toxicology
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