Phase I clinical evaluation of a neutralizing monoclonal antibody against epidermal growth factor receptor in

T Crombet1, O Torres, V Rodríguez

  • 1Center of Molecular Immunology, Havana, Cuba. Taniac@ict.cim.sld.cu

Hybridoma
|June 8, 2001
PubMed

Insights

This study evaluated Ior egf/r3, a monoclonal antibody targeting epidermal growth factor receptor (EGF-R), in brain tumor patients. The antibody showed manageable toxicity and potential for disease stabilization in gliomas and meningiomas.

Area of Science:

  • Oncology
  • Immunology
  • Biotechnology

Background:

  • Overexpression of epidermal growth factor receptor (EGF-R) is common in gliomas and meningiomas.
  • Monoclonal antibodies targeting EGF-R offer a potential therapeutic strategy for brain tumors.

Purpose of the Study:

  • To evaluate the toxicity, immunogenicity, and clinical benefit of escalating doses of the neutralizing murine monoclonal antibody (MAb) Ior egf/r3 in brain tumor patients.
  • To assess the safety and efficacy of Ior egf/r3 in patients with recurrent or active gliomas and meningiomas.

Main Methods:

  • A clinical trial involving nine patients with gliomas or meningiomas receiving four intravenous doses of Ior egf/r3 (160-480 mg total dosage).
  • Inclusion criteria included radioimmunoscintigraphy using 99mTechnetium-labeled Ior egf/r3 MAb.
  • Evaluation of immune response against the murine antibody, including human anti-mouse antibodies (HAMA) development.

Main Results:

  • No significant toxicity was observed, except for one patient experiencing a grade 4 allergic event, possibly due to prior sensitization and HAMA response.
  • Eight out of nine patients achieved stable disease at the 6-month evaluation.
  • Two patients remained alive four years after initiating MAb therapy, indicating long-term survival benefit.

Conclusions:

  • Ior egf/r3 MAb demonstrates a favorable safety profile and potential for disease stabilization in patients with gliomas and meningiomas.
  • Further investigation into the immunogenicity and therapeutic potential of Ior egf/r3 in brain tumors is warranted.

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