ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009
Phase I dose escalation, pharmacokinetic and pharmacodynamic study of naptumomab estafenatox alone in patients with advanced cancer and with docetaxel in patients with advanced non-small-cell lung cancer.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
27 citing papers in PubMed.
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- Tumor-targeted superantigens produce curative tumor immunity with induction of memory and demonstrated antigen spreading.Journal of translational medicine · 2023Article
- Is more better? An analysis of toxicity and response outcomes from dose-finding clinical trials in cancer.BMC cancer · 2021Article
- Evolution ofInternational journal of molecular sciences · 2020Review
- Preclinical development of T-cell receptor-engineered T-cell therapy targeting the 5T4 tumor antigen on renal cell carcinoma.Cancer immunology, immunotherapy : CII · 2019Article
- Incidence of Capillary Leak Syndrome as an Adverse Effect of Drugs in Cancer Patients: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2019Article
- Two-stage design for phase I-II cancer clinical trials using continuous dose combinations of cytotoxic agents.Journal of the Royal Statistical Society. Series C, Applied statistics · 2019Article
- Comparison between continuous and discrete doses for model based designs in cancer dose finding.PloS one · 2019Article
- Factors Affecting the Pharmacology of Antibody-Drug Conjugates.Antibodies (Basel, Switzerland) · 2018Review
- 5T4 oncofoetal antigen: an attractive target for immune intervention in cancer.Cancer immunology, immunotherapy : CII · 2017Review
- Immunotoxin Therapy for Lung Cancer.Chinese medical journal · 2017Article
- Escalation with Overdose Control is More Efficient and Safer than Accelerated Titration for Dose Finding.Entropy (Basel, Switzerland) · 2015Article
- Structure of Staphylococcal Enterotoxin E in Complex with TCR Defines the Role of TCR Loop Positioning in Superantigen Recognition.PloS one · 2015Article
- Adaptive dose-finding studies: a review of model-guided phase I clinical trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Review
- Mechanistic considerations for the use of monoclonal antibodies for cancer therapy.Cancer biology & medicine · 2014Review
- Escalation with overdose control using all toxicities and time to event toxicity data in cancer Phase I clinical trials.Contemporary clinical trials · 2014Article
- Naptumomab estafenatox: targeted immunotherapy with a novel immunotoxin.Current oncology reports · 2014Review
- Article
- Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
purposeTwo phase I studies were conducted of ABR-217620 alone or in combination with docetaxel. This is a recombinant fusion protein consisting of a mutated variant of the superantigen staphylococcal enterotoxin E (SEA/E-120) linked to fragment antigen binding moiety of a monoclonal antibody recognizing the tumor-associated antigen 5T4. PATIENTS AND
methodsPatients with non-small-cell lung cancer (NSCLC), pancreatic cancer (PC), and renal cell cancer (RCC) received 5 daily boluses of ABR-217620 (3-month cycles) in escalating doses to determine the maximum-tolerated dose (MTD; ABR-217620 dose escalation monotherapy [MONO] study). Doses were selected based on individual patient anti-SEA/E-120 titers pretreatment. Patients with NSCLC received 4 daily, escalating doses of ABR-217620 followed by docetaxel in 21-day cycles (ABR-217620 dose escalation combination with docetaxel [COMBO] study).
resultsThirty-nine patients were enrolled in the MONO study and 13 were enrolled in the COMBO study. The monotherapy MTD was 26 microg/kg (NSCLC and PC) and 15 microg/kg (RCC). Dose-limiting toxicities (DLTs) in the MONO study were fever, hypotension, acute liver toxicity, and vascular leak syndrome. In the COMBO study, the MTD was 22 microg/kg (neutropenic sepsis). Adverse events included grade 1 to 2 fever, hypotension, nausea, and chills. Treatment caused a systemic increase of inflammatory cytokines and selective expansion of SEA/E-120 reactive T-cells. Tumor biopsies demonstrated T-cell infiltration after therapy. Fourteen patients (36%) had stable disease (SD) on day 56 of the MONO study. Two patients (15%) in the COMBO study had partial responses, one in a patient with progressive disease on prior docetaxel, and five patients (38%) had SD on day 56.
conclusionABR-217620 was well tolerated with evidence of immunological activity and antitumor activity.
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