First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
Start Date
10/25/2021
Completion Date
6/29/2029
Summary
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: * How safe is BAY2927088 for the participants? * What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? * How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: * The number of participants with medical problems, also called adverse events and serious adverse events, and their severity * The number of participants who discontinue study treatment due to an adverse event. * The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 * Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level * The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088 * The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part * How well does BAY2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: * The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. * The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part. * The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. * The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: * take blood and urine samples, * check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, * check the participants' overall health and heart health, * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BAY2927088_formulation A
BAY2927088_formulation B_1
BAY2927088_formulation B_2
BAY2927088_formulation B_3
Conditions
Locations
Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Gilbert, Arizona 85234
United States
City of Hope - Duarte Cancer Center
Duarte, California 91010
United States
Emory Winship Cancer Institute
Atlanta, Georgia 30322
United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts 02215
United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan 48202
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United States
NYU Langone Hospital - Long Island - Urology
Mineola, New York 11501
United States
Tennessee Oncology - Nashville Centennial Clinic
Nashville, Tennessee 37203
United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas 77030
United States
Virginia Cancer Specialists, PC - Fairfax
Fairfax, Washington 22031
United States
UZ Leuven Gasthuisberg - Pneumology Department
Leuven, Flemish Brabant 3000
Belgium
AZ Delta | Clinical Trial Center - Pneumology
Roeselare, West Flanders 8800
Belgium
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
Natal, Rio Grande do Norte 59040-000
Brazil
Hospital de Base | Integrated Research Center
São José do Rio Preto, São Paulo 15090-000
Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
São Paulo, São Paulo 05651-901
Brazil
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality 100142
China
Beijing Hospital
Beijing, Beijing Municipality 100730
China
Fujian Cancer Hospital
Fuzhou, Fujian 350014
China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
China
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
Wuhan, Hubei 430023
China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan 410013
China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu 210008
China
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
Taizhou, Jiangsu 317000
China
Qilu Hosp., Shandong Univ.
Jinan, Shandong 250012
China
Shandong University - Shandong Cancer Hospital
Jinan, Shandong 250117
China
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality 200030
China
West China Hospital Sichuan University
Chengdu, Sichuan 610041
China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang 310016
China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
China
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
Lyon, Auvergne-Rhône-Alpes 69373
France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, New Aquitaine 33000
France
Hopital Nord Laennec - Oncologie medicale thoracique et digestive
Nantes, Pays de la Loire Region 44093
France
Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale
Saint-Herblain, Pays de la Loire Region 44800
France
AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie
Marseille, Provence-Alpes-Côte d'Azur Region 13005
France
Institut Curie - Paris - Oncologie medicale
Paris, Île-de-France Region 75248
France
Gustave Roussy - Departement Oncologie-Radiotherapie
Villejuif, Île-de-France Region 94805
France
Prince of Wales Hospital
Hong Kong, Hong Kong SAR 00000
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong SAR 00000
Hong Kong
Hong Kong United Oncology Centre
Kowloon, 00000
Hong Kong
Rabin Medical Center | Beilinson Hospital - Nephrology and Hypertension Institute
Petah Tikva, 4941492
Israel
Chaim Sheba Medical Center
Ramat Gan, 5262000
Israel
Istituto Nazionale Tumori IRCCS Fondazione G.Pascale
Naples, Campania 80131
Italy
Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica
Parma, Emilia-Romagna 43126
Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
Aviano, Friuli Venezia Giulia 33081
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
Rome, Lazio 00128
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Lombardy 20133
Italy
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Milan, Lombardy 20141
Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Lombardy 20089
Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
Orbassano, Piedmont 10043
Italy
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
Verona, 37134
Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Kindai University Hospital
Sakai, Osaka 590-0197
Japan
Shizuoka Cancer Center
Sunto, Shizuoka 411-8777
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Tottori University Hospital
Yonago, Tottori 683-8504
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Radboud University Medical Center | Afdeling Interne Geneeskunde
Nijmegen, Gelderland 6500 HB
Netherlands
Nederlands Kanker Instituut
Amsterdam, North Holland 1066 CX
Netherlands
Erasmus University Medical Center | Research Department - Lung Diseases
Rotterdam, South Holland 3015 GD
Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi
Lodz, 92-213
Poland
START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte
Lisbon, 1649-028
Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
Lisbon, 1649-035
Portugal
IPO Porto
Porto, 4200-072
Portugal
National University Hospital Medical Centre
Singapore, 119074
Singapore
National Cancer Center Singapore - Oncology Department
Singapore, 168583
Singapore
Curie Oncology | Mount Elizabeth Novena
Singapore, 329563
Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
St.Vincent's Hospital
Suwon, Gyeonggi-do 16247
South Korea
Chungbuk National University Hospital | Hematology and Oncology
Chungcheongbuk-do, North Chungcheong 28644
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, 03722
South Korea
Asan Medical Center | Oncology
Seoul, 05505
South Korea
Samsung Medical Center - Oncology Department
Seoul, 06351
South Korea
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
Barcelona, 08028
Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035
Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
Madrid, 28040
Spain
Hospital Universitario Hm Sanchinarro | Oncologia
Madrid, 28050
Spain
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, 29010
Spain
Hospital Universitario Y Politecnico La Fe | Oncologia
Valencia, 46026
Spain
Chung Shan Medical University Hospital
Taichung, 402306
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
Chi-Mei Medical Center, Liouyine
Tainan, 73657
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
Taipei, 23561
Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan, 33305
Taiwan