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A phase 1 dose-escalation study of antibody BI-505 in relapsed/refractory multiple myeloma.

In English

Författare

  • Markus Hansson
  • Peter Gimsing
  • Ashraf Z Badros
  • Titti Martinsson Niskanen
  • Hareth Nahi
  • Fritz Offner
  • Morten Salomo
  • Elisabeth Sonesson
  • Morten Mau-Sorensen
  • Yvonne Stenberg
  • Annika Sundberg
  • Ingrid Teige
  • Jan van Droogenbroeck
  • Stina Wichert
  • Maurizio Zangari
  • Bjorn Frendeus
  • Magnus Korsgren
  • Martine Poelman
  • Guido Tricot
Visa allt

Summary, in English

Purpose: This multicenter, first-in-human study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of BI-505, a human anti-ICAM-1 monoclonal antibody, in advanced relapsed/refractory multiple myeloma patients. Experimental design: BI-505 was given intravenously, every two weeks, at escalating doses from 0.0004 to 20 mg/kg, with extension of therapy until disease progression for responding or stable patients receiving 0.09 mg/kg or higher doses. Results: A total of 35 patients were enrolled. The most common adverse events were fatigue, pyrexia, headache, and nausea. Adverse events were generally mild to moderate and those attributed to study medication were mostly limited to the first dose, and manageable with premedication and slower infusion. No maximum tolerated dose was identified. BI-505's half-life increased with dose while clearance decreased, suggesting target-mediated clearance. The ICAM-1 epitopes on patient bone marrow myeloma were completely saturated at 10 mg/kg doses. Using the International Myeloma Working Group criteria, seven patients on extended therapy had stable disease for more than two months. Conclusion: BI-505 can be safely administered at doses that saturate myeloma cell ICAM-1 receptors in patients. This study was registered at www.clinicaltrials.gov (NCT01025206).

Avdelning/ar

Publiceringsår

2015

Språk

Engelska

Sidor

2730-2736

Publikation/Tidskrift/Serie

Clinical Cancer Research

Volym

21

Issue

12

Dokumenttyp

Artikel i tidskrift

Förlag

American Association for Cancer Research

Ämne

  • Cancer and Oncology

Status

Published

Forskningsgrupp

  • Myeloma research group
  • Immunology

ISBN/ISSN/Övrigt

  • ISSN: 1078-0432