Phase 1 and Pharmacokinetic Study of Lexatumumab in Patients with Advanced Cancers

  • Plummer R
  • Attard G
  • Pacey S
 et al. 
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Purpose:To assess the safety and tolerability, pharmacokinetics, and early evidence of antitumor activity of escalating doses of lexatumumab (HGS-ETR2), a fully human agonistic monoclonal antibody which targets and activates the tumor necrosis factor ^ related apoptosis-inducing ligand receptor 2 (TRAIL-R2) in patients with advanced solid malignancies. Experimental Design: In this phase 1, open label study, patients with advanced solid malignan-cies were treated with escalating doses of lexatumumab administered i.v. over 30 to120 min every 21days. A cohort of four patients, which could be expanded to six patients, was studied at each dose level. The dose-limiting toxicity (DLT) dose was defined as the dose at which the incidence of DLT in the first two cycles was z33%.The maximum tolerated dose was defined as the highest dose at which

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  • Ruth Plummer

  • Gerhardt Attard

  • Simon Pacey

  • Louise Li

  • Albiruni Razak

  • Rebecca Perrett

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