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Brief Title: 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)
Official Title: An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation
Study ID: NCT05099172
Brief 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, 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 BAY 2927088 * The (average) highest level of BAY 2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part * How well does BAY 2927088 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 BAY 2927088 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
City of Hope-Cancer Department, Duarte, California, United States
Emory University, Atlanta, Georgia, United States
The Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System | Brigitte Harris Cancer Pavilion, Detroit, Michigan, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
NYU Langone Health, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
UZ Leuven Gasthuisberg, Leuven, , Belgium
AZ Delta | Clinical Trial Center - Pneumology, Roeselare, , Belgium
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica, Natal, Rio Grande Do Norte, Brazil
Hospital de Base | Integrated Research Center, São José do Rio Preto, Sao Paulo, Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department, Sao Paulo, , Brazil
Fujian Cancer Hospital, Fuzhou, Fujian, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing, Jiangsu, China
Qilu Hosp., Shandong Univ., Jinan, Shandong, China
West China Hospital Sichuan University, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
Shandong University - Shandong Cancer Hospital, Jinan, , China
Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, , China
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province, Taizhou, , China
Institut Bergonié - Unicancer Nouvelle Aquitaine, Bordeaux Cedex, , France
Centre Léon Bérard, Lyon, , France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord, Marseille, , France
Hôpital Nord Laennec - Oncologie médicale thoracique et digestive, Nantes, , France
Institut Curie - Ulm - Paris, PARIS cedex 5, , France
Institut de Cancérologie de l'Ouest - Saint Herblain, Saint-Herblain, , France
Institut Gustave Roussy - Département de Médecine Oncologique, Villejuif Cedex, , France
Queen Mary Hospital, Hong Kong, , Hong Kong
Hong Kong United Oncology Centre, Kowloon, , Hong Kong
Prince of Wales Hospital, Shatin, , Hong Kong
Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Istituto Nazionale Tumori IRCCS Fondazione G.Pascale, Napoli, Campania, Italy
A.O.U. di Parma, Parma, Emilia-Romagna, Italy
IRCCS Centro di Riferimento Oncologico (CRO), Pordenone, Friuli-Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A., Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO), Milano, Lombardia, Italy
A.O.U. San Luigi Gonzaga, Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI), Verona, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Okayama University Hospital, Okayama-city, Okayama, Japan
Shizuoka Cancer Center, Sunto, Shizuoka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Tottori University Hospital, Yonago, Tottori, Japan
Kindai University Hospital, Osakasayama-shi, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbugdo, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, Korea, Republic of
St.Vincent's Hospital, Suwon-si, Gyeonggido, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Nederlands Kanker Instituut, Amsterdam, , Netherlands
Radboud University Medical Center | Afdeling Interne Geneeskunde, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow, Lodz, , Poland
START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte, Lisbon, Lisboa, Portugal
CHULN - H. Sta.Maria (Centro de Investigacao Clinica), Lisboa, , Portugal
IPO Porto, Porto, , Portugal
National University Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Curie Oncology, Singapore, , Singapore
Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Hospital Quiron Dexeus, Barcelona, , Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion), Madrid, , Spain
Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Universitario Virgen de la Victoria | Oncology, Málaga, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Chung Shan Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi-Mei Medical Center, Liouyine, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH), Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou, Taoyuan, , Taiwan