NCT00796055 (Clinical Trial / MEDI-547)

Study Title
Study of MEDI-547 to Evaluate the Safety, Tolerability, and Biologic Activity of IV Administration in Subjects With Relapsed or Refractory Solid Tumors (NCT00796055)

Trial Description
To determine the safety, tolerability, and the highest dose of this drug given once every 3 weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory solid tumors.

Drug Description
MEDI-547 is an auristatin analogue immunoconjugate or antibody-drug conjugate (ADC) directed against Eph receptor A2 (EphA2)-positive cancer cells with potential antineoplastic activity. The trial drug is generated by conjugating the fully human IgG1 anti-EphA2 monoclonal antibody (1C1) to the small-molecule microtubule inhibitor monomethyl auristatin phenylalanine (MMAF) via the stable linker maleimidocaproyl (mc) (1C1-mcMMAF).

The monoclonal antibody moiety of this agent selectively binds to cells expressing the EphA2 receptor. After internalization and enzymatic cleavage of the immunoconjugate within the tumor cell cytosol, free MMAF binds to tubulin and inhibits its polymerization, which may result in G2/M phase arrest and tumor cell apoptosis. The cell-surface receptor EphA2, a member of the ephrin family of receptor tyrosine kinases or RTKs involved in mammalian development, is overexpressed by a variety of different cancer cell types.

This trial is sponsored by MedImmune [1]

Study Data

  • Condition: Cancer
  • Interventions:
    • Drugs used in this trial
      • MEDI-547
  • Phase:
  • Enrollment: 6
  • Start: August 2009
  • Completion: June 2010
  • Last verified: November 2011

Study Schematic 

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Last Editorial review: August 10, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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