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Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas

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Title: Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas
Authors: Wermke, Martin, Felip, Enriqueta, Gambardella, Valentina, Kuboki, Yasutoshi, Morgensztern, Daniel, Hamed, Zohra Oum', Liu, Meiruo, Studeny, Matus, Owonikoko, Taofeek K
Contributors: Institut Català de la Salut, [Wermke M] Technical University Dresden, Medical Faculty, NCT/UCC Early Clinical Trial Unit, Dresden, Germany. [Felip E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Gambardella V] Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain. [Kuboki Y] Department of Experimental Therapeutics, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. [Morgensztern D] Washington University School of Medicine, St. Louis, MO 63110, USA. [Hamed ZO] Boehringer Ingelheim France S.A.S., Reims, France, Vall d'Hebron Barcelona Hospital Campus
Source: FUTURE ONCOLOGY
r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname
Scientia
Scientia. Dipòsit d'Informació Digital del Departament de Salut
Publisher Information: Informa UK Limited, 2022.
Publication Year: 2022
Subject Terms: Lung Neoplasms, Other subheadings::Other subheadings::/therapeutic use, T-Lymphocytes, Otros calificadores::Otros calificadores::/uso terapéutico, DLL3, Phase I as Topic, Antibodies, DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neuroendocrine Tumors::Carcinoma, Neuroendocrine, BI 764532, Mice, 03 medical and health sciences, 0302 clinical medicine, Antibodies, Bispecific, Medicine and Health Sciences, small-cell lung cancer, Animals, Humans, Multicenter Studies as Topic, Clinical Trials, DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Small Cell Lung Carcinoma, COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos biespecíficos, Anticossos monoclonals - Ús terapèutic, Clinical Trials, Phase I as Topic, T-cell engager, Carcinoma, neuroendocrine carcinoma, Intracellular Signaling Peptides and Proteins, Membrane Proteins, Tumors neuroendocrins - Tractament, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas, Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine, 3. Good health, Neuroendocrine, Neoplasm Recurrence, Local, CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Bispecific, Bispecific, Neoplasm Recurrence, Local, Pulmons - Càncer - Tractament, ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::tumores neuroendocrinos::carcinoma neuroendocrino
Description: Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
Document Type: Article
File Description: application/pdf
Language: English
ISSN: 1744-8301
1479-6694
DOI: 10.2217/fon-2022-0196
Access URL: https://pubmed.ncbi.nlm.nih.gov/35815644
https://incliva.fundanetsuite.com/publicaciones/ProdCientif/PublicacionFrw.aspx?id=17174
https://hdl.handle.net/11351/8197
Rights: CC BY NC ND
Accession Number: edsair.doi.dedup.....8e83791285194b01116298cd0de0ee7c
Database: OpenAIRE
Description
Abstract:Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
ISSN:17448301
14796694
DOI:10.2217/fon-2022-0196