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Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Sponsor: BioNTech SE
Summary
This first-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The trial will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, and resectable NSCLC of Stage II and III in Cohort 6.
Official title: LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2022-06-17
Completion Date
2031-11
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Docetaxel
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
BNT316
Intravenous infusion
anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
anti-HER3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
Bispecific antibody for PD-L1 and VEGF-A
Intravenous infusion
Locations (45)
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Universitätsklinikum Köln
Cologne, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, Hungary
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, Hungary
National Institute of Oncology
Budapest, Hungary
Clinexpert Ltd
Gyöngyös, Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland
NZOZ Medpolonia Sp. Z o.o
Poznan, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Adana Sehir Hospital
Adana, Turkey (Türkiye)
Haceteppe Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Koc University Hospital
Istanbul, Turkey (Türkiye)
University Medical Faculty Oncology Institute
Istanbul, Turkey (Türkiye)
Yeditepe University
Istanbul, Turkey (Türkiye)
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, Turkey (Türkiye)
Dokuz Eylul Medical School
Izmir, Turkey (Türkiye)
Adana Sehir Hospital
Yüreğir, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Velindre NHS Trust
Cardiff, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom