Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Start Date
6/17/2022
Completion Date
11/1/2031
Summary
This first-in-human (FIH) study 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, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, 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 study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study 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, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
Detailed Description
The maximum duration of treatment for each individual participant in this study is: * Cohorts 1 to 4, Cohorts 7 to 10, Cohort EGFR, and Cohort ALK/RET: 24 months. * Cohorts 5 and 11: 18 cycles, i.e., 12 months. * Cohort 6: 4 cycles of neo-adjuvant treatment and 18 cycles of adjuvant treatment, i.e., 12 months of adjuvant treatment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BNT116
Cemiplimab
Docetaxel
Carboplatin
Paclitaxel
BNT316
anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
anti-HER3 antibody conjugated to topoisomerase I inhibitor
Bispecific antibody for PD-L1 and VEGF-A
Osimertinib
ALK-inhibitor or RET-inhibitor
Conditions
Locations
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536
United States
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Ohio State University
Columbus, Ohio 43210
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Scientia Clinical Research
Randwick, New South Wales 2031
Australia
Royal North Shore Hospital
Sydney, New South Wales 2065
Australia
Cancer Research SA
Adelaide, South Australia 5000
Australia
Monash Health
Clayton, Victoria 3168
Australia
Universitätsklinikum Köln
Cologne, 50937
Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, 60488
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, 55131
Germany
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, 1077
Hungary
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, 1083
Hungary
National Institute of Oncology
Budapest, 1122
Hungary
Clinexpert Ltd
Gyöngyös, 3200
Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357
Poland
NZOZ Medpolonia Sp. Z o.o
Poznan, 60-693
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Poland
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, 08916
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
MD Anderson Cancer Center
Madrid, 28033
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
Spain
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, 15706
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Spain
Adana City Training and Research Hospital
Adana, 01370
Turkey (Türkiye)
Haceteppe Hospital
Ankara, 06100
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800
Turkey (Türkiye)
Koc University Hospital
Istanbul, 34010
Turkey (Türkiye)
University Medical Faculty Oncology Institute
Istanbul, 34093
Turkey (Türkiye)
Yeditepe University
Istanbul, 34718
Turkey (Türkiye)
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, 35100
Turkey (Türkiye)
Dokuz Eylul Medical School
Izmir, 35330
Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United Kingdom
Velindre NHS Trust
Cardiff, CF14 2TL
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA
United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT
United Kingdom
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
United Kingdom