Phase I clinical trial of the bispecific antibody MDX-H210 (anti-FcγRI × anti-HER-2/neu) in combination with Filgrastim (G-CSF) for treatment of advanced breast cancer
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A phase I study of the bispecific antibody MDX-H210 in combination with granulocyte colony-stimulating factor (G-CSF) was performed in stage IV breast carcinoma patients, overexpressing HER-2/neu. MDX-H210, constructed by crosslinking antigen binding fragments (F(ab') fragments) of monoclonal antibody (mAb) H22 to Fc gamma receptor I (FcgammaRI), and mAb 520C9 to HER-2/neu, respectively, mediates the lysis of tumour cells in vitro, and in human FcgammaRI transgenic mouse models. The proto-oncogene HER-2/neu is overexpressed in approximately 30% of breast cancer patients, and represents a promising target for antibody-based immunotherapy. Fc gamma receptor I (CD64) is an effective trigger molecule, which is expressed on monocytes/macrophages, immature dendritic cells, and G-CSF-primed polymorphonuclear cells (PMN). Patients received G-CSF (Filgrastim) for 8 consecutive days, and cohorts of three patients were treated on day 4 with escalating, single doses of MDX-H210. A total of 30 patients were included, and treatment was generally well tolerated, without reaching dose-limiting toxicity. Side effects consisted mainly of fever and short periods of chills, which were timely related to elevated plasma levels of interleukin 6 and tumour necrosis factor alpha. In the last two cohorts, MDX-H210 plasma levels exceeded 1 microg ml(-1), and on circulating myeloid cells >50% saturation of FcgammaRI was found until day 4. These effector cells were highly effective in antibody-dependent cell-mediated cytotoxicity. Immunohistochemical analyses of tumour biopsies in individual patients documented infiltration of monocytes and PMN after MDX-H210 infusion. Although the clinical course of the disease was not altered by the single dose of MDX-H210, a favourable toxicity profile--even at high doses--and remarkable biological effects were seen when combined with G-CSF. Therefore, the combination of G-CSF and MDX-H210 should be evaluated in further immunotherapeutical strategies.
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Biological effects were seen in some clinical trials of MDX-210, MDX-H210 and MDX-447, but none of these treatments led to consistent antitumor activity.
“Biological effects were seen in some clinical trials of bsAbs MDX-210 (targeting Her2 and CD64), MDX-H210 (humanized version of MDX-210) and MDX-447 (targeting EGFR and CD64), but none of these treatments led to consistent antitumor activity. [9][10]0][11][12]”
From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [10]
Chemically linked bispecific (Fab')2 molecules targeting HER2 or EGFR were tested in clinical trials; these antigens are overexpressed in many epithelial tumors such as colorectal, head and neck, bladder, renal, and non-small cell lung carcinoma.
“A series of clinical trials were also performed with chemically linked bispecific (Fab')2 molecules targeting the breast and ovarian cancer tumor antigens HER2 or EGFR, [9][10][11][12] which are overexpressed in many epithelial tumors such as colorectal, head and neck, bladder, renal, non-small cell lung carcinoma.”
From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [10]
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- Authors
- Repp, R., van Ojik, H. H., Valerius, T., Groenewegen, G., Wieland, G., Oetzel, C., Stockmeyer, B., Becker, W., Eisenhut, M., Steininger, H., Deo, Y. M., Blijham, G. H., Kalden, J. R., van de Winkel, J. G. J., & Gramatzki, M.
- Affiliations
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University Medical Center Utrecht (NL)
- University of Göttingen (DE)
- Heidelberg University (DE)
- Corresponding author
- Repp, R
- Venue
- British Journal of Cancer
- Published
- 2003-12
- Volume
- 89
- Issue
- 12
- Pages
- 2234-2243
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC2395280
- OpenAlex
- W2153024287
- Cited by
- 88
- References
- 39
- Citations by year
- 2025: 3 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 4 · 2020: 1 · 2019: 3 · 2018: 3 · 2017: 2 · 2016: 1 · 2014: 7 · 2013: 5 · 2012: 5
- FWCI
- 2.09
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- www.springer.com/tdm (unspecified)
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- GRO (submittedVersion, cc-by)
- Funders
- Dartmouth College
- Deutsche Forschungsgemeinschaft
- KWF Kankerbestrijding
- Topics
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Immune Cell Function and Interaction
- Keywords
- bispecific antibodies, Fc gamma receptor I, HER2/neu, advanced breast cancer, filgrastim, granulocyte colony-stimulating factor, antibody-dependent cellular cytotoxicity, myeloid cell activation, cytokine production, dose-limiting toxicity, immunotherapy
- MeSH terms
- Filgrastim, Proto-Oncogene Mas, Adjuvants, Immunologic, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Breast Neoplasms, Female, Humans, Immunotherapy, Middle Aged, Neoplasm Staging, Recombinant Proteins, Biomarkers, Tumor, Cohort Studies, Granulocyte Colony-Stimulating Factor, Cytokines, Antibodies, Bispecific, Genes, erbB-2, Maximum Tolerated Dose, Antibodies, Monoclonal, Humanized
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