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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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