ArticleInvestigational new drugs2015
A phase 1 study of ABT-806 in subjects with advanced solid tumors.
Article in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed, 37 citations in OpenAlex.
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- Synergistic therapeutic benefit by combining the antibody drug conjugate, depatux-m with temozolomide in pre-clinical models of glioblastoma with overexpression of EGFR.Journal of neuro-oncology · 2021Article
- Antibody Drug Conjugates in Glioblastoma - Is There a Future for Them?Frontiers in oncology · 2021Review
- High-Affinity Chimeric Antigen Receptor With Cross-Reactive scFv to Clinically Relevant EGFR Oncogenic Isoforms.Frontiers in oncology · 2021Article
- Targeting and Efficacy of Novel mAb806-Antibody-Drug Conjugates in Malignant Mesothelioma.Pharmaceuticals (Basel, Switzerland) · 2020Article
- The Latest Battles Between EGFR Monoclonal Antibodies and Resistant Tumor Cells.Frontiers in oncology · 2020Review
- Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial.Neuro-oncology · 2019Article
- RN765C, a low affinity EGFR antibody drug conjugate with potent anti-tumor activity in preclinical solid tumor models.Oncotarget · 2018Article
- Targeted Therapies for Targeted Populations: Anti-EGFR Treatment forCancer discovery · 2018Article
- Epidermal growth factor receptor and EGFRvIII in glioblastoma: signaling pathways and targeted therapies.Oncogene · 2018Review
- Review
- Antibody-Drug Conjugates (ADCs) for Personalized Treatment of Solid Tumors: A Review.Advances in therapy · 2017Review
- Toward the use of precision medicine for the treatment of head and neck squamous cell carcinoma.Oncotarget · 2017Review
- Highly Specific and Effective Targeting of EGFRvIII-Positive Tumors with TandAb Antibodies.Frontiers in oncology · 2017Article
- Receptor tyrosine kinases as druggable targets in glioblastoma: Do signaling pathways matter?Neuro-oncology advancesReview
- Review
Corrections and comments
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Authors and funding
15 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeABT-806, a humanized recombinant monoclonal antibody, binds a unique epidermal growth factor receptor (EGFR) epitope exposed in the EGFRde2-7 (EGFRvIII) deletion mutant and other EGFR proteins in the activated state. This phase I study evaluated the safety, pharmacokinetics, and recommended phase two dose (RP2D) of ABT-806 in patients with solid tumors that commonly overexpress activated EGFR or EGFRvlll.
methodsPatients with advanced solid tumors, including glioblastoma, were eligible. Following a dose escalation phase, expanded safety cohorts of patients with solid tumors or EGFR-amplified glioblastoma were enrolled. Adverse events (AEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events v4.0; tumor response was assessed by Response Evaluation Criteria in Solid Tumors v1.1. EGFR protein expression was quantified by immunohistochemistry.
results49 patients were treated. Frequent AEs (≥10 %) possibly/probably related to ABT-806 were fatigue (18 %), nausea (16 %), dermatitis acneiform (12 %), and vomiting (10 %). Only one dose-limiting toxicity (grade three morbilliform rash) occurred. The RP2D was the pre-specified highest dose (24 mg/kg). Systemic exposures were dose proportional between 2 and 24 mg/kg. Median time to progression was 55 days (95 % confidence interval, 53-57) in all patients and 43 days (22-57) for glioblastoma patients. No objective responses occurred; however, two patients had prolonged stable disease. An EGFR-amplified penile cancer patient has stable disease lasting over 2.5 years.
conclusionsABT-806 has unique pharmacokinetic and safety profiles. Toxicities were infrequent and typically low grade at the RP2D. Linear ABT-806 pharmacokinetics suggest lack of significant binding to wild-type EGFR in normal tissues.
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