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RECRUITING
NCT05142189
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

BNT116

Intravenous injection

BIOLOGICAL

Cemiplimab

Intravenous infusion

DRUG

Docetaxel

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

BIOLOGICAL

BNT316

Intravenous infusion

BIOLOGICAL

anti-B7-H3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICAL

anti-HER3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICAL

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