do_not_disturb_altRecruitment Complete
Advanced non-small cell lung cancer, EGFR mutation, HER2 mutation
Bayer Identifier:
21607
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-503795-24-00
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)
Trial purpose
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 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.
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 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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
370Trial Dates
October 2021 - December 2026Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
BAY2927088Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | National Taiwan University Hospital | Taipei, 100, Taiwan |
Active, not recruiting | Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit | Detroit, 48202, United States |
Active, not recruiting | Dana-Farber Cancer Institute | Boston, 02215, United States |
Completed | City of Hope - Duarte Cancer Center | Duarte, 91010, United States |
Active, not recruiting | National University Hospital Medical Centre | Singapore, 119074, Singapore |
Active, not recruiting | National Cancer Center Singapore | Singapore, 168583, Singapore |
Active, not recruiting | Shanghai Chest Hospital, Shanghai Jiaotong University | Shanghai, 200030, China |
Active, not recruiting | Beijing Cancer Hospital | Beijing, 100142, China |
Active, not recruiting | West China Hospital Sichuan University | Chengdu, 610041, China |
Active, not recruiting | Zhejiang Cancer Hospital | Hangzhou, 310022, China |
Active, not recruiting | Prince of Wales Hospital | Hong Kong, MISSING, Hong Kong |
Active, not recruiting | Emory Winship Cancer Institute | Atlanta, 30322, United States |
Active, not recruiting | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Active, not recruiting | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Active, not recruiting | Institut Català d'Oncologia Hospitalet | Hospitalet de Llobregat, 08907, Spain |
Active, not recruiting | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Active, not recruiting | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Active, not recruiting | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Active, not recruiting | National Cancer Center Hospital | Chuo-ku, 104-0045, Japan |
Completed | Shizuoka Cancer Center | Sunto, 411-8777, Japan |
Active, not recruiting | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Active, not recruiting | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Withdrawn | Istituto Nazionale Tumori IRCCS Fondazione G.Pascale | Napoli, 80131, Italy |
Active, not recruiting | Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati | Aviano, 33081, Italy |
Active, not recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I | Roma, 00128, Italy |
Not yet recruiting | NYU Langone Health | Mineola, 11501, United States |
Withdrawn | Roswell Park Comprehensive Cancer Center | Buffalo, 14263-0001, United States |
Active, not recruiting | Institut Gustave Roussy - Département de Médecine Oncologique | VILLEJUIF CEDEX, 94805, France |
Active, not recruiting | Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale | Bordeaux, 33000, France |
Active, not recruiting | Institut Curie - Paris - Oncologie medicale | Paris, 75248, France |
Active, not recruiting | Tottori University Hospital | Yonago, 683-8504, Japan |
Active, not recruiting | Osaka International Cancer Institute | Osaka-shi, 541-8567, Japan |
Active, not recruiting | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea,_republic_of |
Active, not recruiting | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Active, not recruiting | Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech | Wuhan, 430023, China |
Active, not recruiting | Hunan Cancer Hospital | Changsha, 410013, China |
Active, not recruiting | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Completed | City of Hope - Duarte Cancer Center | Duarte, 91010, United States |
Active, not recruiting | UZ Leuven Gasthuisberg - Pneumology Department | Leuven, 3000, Belgium |
Active, not recruiting | IPO Porto | Porto, 4200-072, Portugal |
Withdrawn | Hospital Santa Maria | Centro de Investigacao Clinica | MISSING, 1649-035, Portugal |
Completed | Centro Integral Oncológico Clara Campal | Madrid, 28050, Spain |
Active, not recruiting | Hospital Universitari i Politecnic La Fe | Oncologia | Valencia, 46026, Spain |
Active, not recruiting | Hospital Quiron Dexeus | Barcelona, 08028, Spain |
Active, not recruiting | AZ Delta | Clinical Trial Center - Pneumology | Roeselare, 8800, Belgium |
Withdrawn | Uniwersyteckie Centrum Kliniczne | Gdansk, 80-214, Poland |
Withdrawn | SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow | Lodz, 92-213, Poland |
Active, not recruiting | Queen Mary Hospital | Hong Kong, MISSING, Hong Kong |
Active, not recruiting | Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia | Rozzano, 20089, Italy |
Active, not recruiting | Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica | Orbassano, 10043, Italy |
Active, not recruiting | Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica | Parma, 43126, Italy |
Completed | Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative | Milano, 20141, Italy |
Active, not recruiting | Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 | Milano, 20133, Italy |
Recruiting | Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department | Sao Paulo, 05651-901, Brazil |
Active, not recruiting | Harbin Medical University Cancer Hospital | Harbin, 150000, China |
Active, not recruiting | Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine | Hangzhou, 310016, China |
Active, not recruiting | Fujian Cancer Hospital | Fuzhou, 350014, China |
Active, not recruiting | Qilu Hosp., Shandong Univ. | Jinan, 250000, China |
Active, not recruiting | Beijing Hospital | Beijing, 100730, China |
Active, not recruiting | UNICANCER - Centre Leon-Berard (CLB) - Medical oncology | Lyon Cedex 08, 69373, France |
Active, not recruiting | Institut de Cancérologie de l'Ouest - Saint Herblain - Oncologie medicale | Saint Herblain, 44800, France |
Completed | Banner MD Anderson Cancer Center at Banner Gateway Medical Center | Gilbert, 85234, United States |
Active, not recruiting | Virginia Cancer Specialists, PC | Fairfax, 22031, United States |
Recruiting | The Center for Cancer and Blood Disorders | Bethesda, 20817, United States |
Recruiting | Tennessee Oncology | Nashville, 37203, United States |
Active, not recruiting | Chaim Sheba Medical Center | Ramat Gan, 5262000, Israel |
Active, not recruiting | Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department | Petach Tikva, 4941492, Israel |
Active, not recruiting | Nederlands Kanker Instituut | AMSTERDAM, 1066 CX, Netherlands |
Active, not recruiting | Erasmus University Medical Center | Research Department - Lung Diseases | Rotterdam, 3015GD, Netherlands |
Active, not recruiting | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Active, not recruiting | Kanagawa Cancer Center | Yokohama, 241-8515, Japan |
Active, not recruiting | National Hospital Organization Shikoku Cancer Center | Matsuyama, 791-0280, Japan |
Active, not recruiting | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Active, not recruiting | St.Vincent's Hospital | Suwon-si, 16247, Korea,_republic_of |
Active, not recruiting | Chungbuk National University Hospital | Cheongju-si, 28644, Korea,_republic_of |
Active, not recruiting | Chang Gung Memorial Hospital at Linkou | Taoyuan, 33305, Taiwan |
Active, not recruiting | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Recruiting | Hospital de Base | Integrated Research Center | São José do Rio Preto, 15090-000, Brazil |
Active, not recruiting | Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica | Natal, 59040-000, Brazil |
Withdrawn | START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte | Lisbon, 1649-028, Portugal |
Withdrawn | Hopital de la Timone - Marseille - Centre d'Essais en Cancerologie | Marseille, 13005, France |
Active, not recruiting | Hopital Nord Laennec - Oncologie medicale thoracique et digestive | Nantes, 44093, France |
Active, not recruiting | Curie Oncology | Mount Elizabeth Novena | Singapore, 329563, Singapore |
Withdrawn | Hospital Universitario Virgen de la Victoria | Oncology | Málaga, 29010, Spain |
Active, not recruiting | Kindai University Hospital | Osakasayama, 589-8511, Japan |
Active, not recruiting | Okayama University Hospital | Okayama, 700-8558, Japan |
Withdrawn | Radboud University Medical Center | Afdeling Interne Geneeskunde | Nijmegen, 6500 HB, Netherlands |
Completed | Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia | Verona, 37134, Italy |
Active, not recruiting | Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province | Taizhou, 317000, China |
Active, not recruiting | Chi-Mei Medical Center, Liouyine | Tainan, 73657, Taiwan |
Withdrawn | Chung Shan Medical University Hospital | Taichung, 402306, Taiwan |
Withdrawn | Hong Kong United Oncology Centre | Kowloon, Hong Kong |
Active, not recruiting | Samsung Medical Center | Seoul, 6351, Korea,_republic_of |
Withdrawn | Taipei Medical University (TMU) - Shuang Ho Hospital (SHH) | Taipei, 23561, Taiwan |
Active, not recruiting | Shandong University - Shandong Cancer Hospital | Jinan, 250117, China |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 30 days after the last administration of study treatment
- Number of participants with treatment-emergent serious adverse events (TESAEs)date_rangeTime Frame:Up to 30 days after the last administration of study treatment
- Severity of TEAEsdate_rangeTime Frame:Up to 30 days after the last administration of study treatment
- Severity of TESAEsdate_rangeTime Frame:Up to 30 days after the last administration of study treatment
- Number of participants who discontinue study treatment due to an AEdate_rangeTime Frame:About 4 years (Up to the end of study treatment)
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)date_rangeTime Frame:At the end of Cycle 1 of a 21-day cycle
- Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)In Dose Escalation (including participants from Backfill)date_rangeTime Frame:At the end of Cycle 1 of a 21-day cycle
- Cmax of BAY2927088Cmax: Maximum/peak concentrationdate_rangeTime Frame:Cycle 1, Day 1 (Cycle duration is 21 days)
- AUC(0-24) of BAY2927088 for QDAUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)date_rangeTime Frame:Cycle 1, Day 1 (Cycle duration is 21 days)
- AUC(0-12) of BAY2927088 for BIDIf applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.date_rangeTime Frame:Cycle 1, Day 1 (Cycle duration is 21 days)
- Cmax,md of BAY2927088Cmax,md: Cmax after multiple dose administrationsdate_rangeTime Frame:Cycle 1, Day 15 (Cycle duration is 21 days)
- AUC(0-24)md of BAY2927088 for QDAUC(0-24)md: AUC(0-24) after multiple dose administrationsdate_rangeTime Frame:Cycle 1, Day 15 (Cycle duration is 21 days)
- AUC(0-12)md of BAY2927088 for BIDIf applicable AUC(0-12)md: AUC(0-12) after multiple dose administrationsdate_rangeTime Frame:Cycle 1, Day 15 (Cycle duration is 21 days)
- Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
Secondary Outcome
- Overall response rate (ORR) as per RECIST v1.1 by investigator assessmentRECIST v1.1: Response Evaluation Criteria in Solid Tumors, version 1.1date_rangeTime Frame:About 4 years
- Recommended phase 2 dose (RP2D) of BAY2927088date_rangeTime Frame:About 1.5 years
- ORR per RECIST v1.1 by Investigator assessment in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
- Disease control rate (DCR) per RECIST v1.1 by Investigator assessment and BICR in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
- Duration of response (DOR) per RECIST 1.1 by Investigator assessment and BICR in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
- Progression-free survival (PFS) per RECIST 1.1 by Investigator assessment and BICR in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
- Overall survival (OS) in extension partdate_rangeTime Frame:From the start of the study treatment up to 12 months
- Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity in extension partdate_rangeTime Frame:Up to 30 days after the last administration of study treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
4