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)

NCT05099172 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 216072023-503795-24-002021-003022-77
• Study Type: interventional
• Target: 400
• Locations: 16 countries
• Sites: 94

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, 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.

Conditions

EGFR Mutation; HER2 Mutation; Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (14)

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to 30 days after the last administration of study treatment

• Number of participants with treatment-emergent serious adverse events (TESAEs)

  Up to 30 days after the last administration of study treatment

• Severity of TEAEs

  Up to 30 days after the last administration of study treatment

• Severity of TESAEs

  Up to 30 days after the last administration of study treatment

• Number of participants who discontinue study treatment due to an AE

  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)

  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)

  At the end of Cycle 1 of a 21-day cycle

• Cmax of BAY2927088

  Cmax: Maximum/peak concentration

  Cycle 1, Day 1 (Cycle duration is 21 days)

• AUC(0-24) of BAY2927088 for QD

  AUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)

  Cycle 1, Day 1 (Cycle duration is 21 days)

• AUC(0-12) of BAY2927088 for BID

  If applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.

  Cycle 1, Day 1 (Cycle duration is 21 days)

• Cmax,md of BAY2927088

  Cmax,md: Cmax after multiple dose administrations

  Cycle 1, Day 15 (Cycle duration is 21 days)

• AUC(0-24)md of BAY2927088 for QD

  AUC(0-24)md: AUC(0-24) after multiple dose administrations

  Cycle 1, Day 15 (Cycle duration is 21 days)

• AUC(0-12)md of BAY2927088 for BID

  If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations

  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 part

  From the start of the study treatment up to 12 months

Secondary Outcomes (8)

• Overall response rate (ORR) as per RECIST v1.1 by investigator assessment

  About 4 years

• Recommended phase 2 dose (RP2D) of BAY2927088

  About 1.5 years

• ORR per RECIST v1.1 by Investigator assessment in extension part

  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 part

  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 part

  From the start of the study treatment up to 12 months

Study Arms (4)

Dose escalation

EXPERIMENTAL

Doses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD.

Drug: BAY2927088_formulation A; Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2

Backfill

EXPERIMENTAL

Dose Escalation and Backfill run concurrently

Drug: BAY2927088_formulation A; Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2

Dose expansion

EXPERIMENTAL

Eight independent groups (group A, B1, B2, C, D, E, F, G, H) are planned. Dose Expansion may start at a dose level that has been evaluated in Escalation/Backfill in at least 9 participants and considered safe or at any other dose levels that are below the highest dose level that is considered safe.

Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2; Drug: BAY2927088_formulation B_3

Extension part

EXPERIMENTAL

Initiation of the Extension part will depend on the benefit-risk profile observed during Dose Expansion. Additionally, enrollment may be prematurely terminated based on emerging data at the discretion of the Sponsor.

Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2

Interventions

BAY2927088_formulation B_3 DRUG

Oral administration

Dose expansion

BAY2927088_formulation B_1 DRUG

Oral administration

Backfill; Dose escalation; Dose expansion; Extension part

BAY2927088_formulation B_2 DRUG

Oral administration

Backfill; Dose escalation; Dose expansion; Extension part

BAY2927088_formulation A DRUG

Oral administration

Backfill; Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).
• Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.
• Note: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.
• Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.
• Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.
• Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \[US\] sites) or an equally accredited (outside of the US) local laboratory.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:
• Hemoglobin ≥ 9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.
• Platelets ≥ 100 × 10\^9 cells/L.
• Absolute neutrophil count ≥ 1.5 ×10\^9 cells/L. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.
• Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:
• a. Estimated glomerular filtration rate (eGFR) \> 50 mL/min per 1.73 m\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.
• Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:

You may not qualify if:

• Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.
• Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.
• Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.
• Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.
• Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
• Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).
• History of spinal cord compression or brain metastases with the following exceptions:
• Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.
• Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Group G and Group H) if all of the following criteria are met:
• there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
• Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.
• Participants with history of spinal cord compression \>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.
• Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg/day dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.
• History of congestive heart failure (CHF) Class \>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec).
• Participants with:

Sponsors & Collaborators

• Bayer: lead

Study Sites (94)

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, Arizona, 85234, United States

COMPLETED

City of Hope - Duarte Cancer Center

Duarte, California, 91010, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

TERMINATED

Dana-Farber Cancer Institute - Oncology Department

Boston, Massachusetts, 02215, United States

COMPLETED

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

WITHDRAWN

NYU Langone Hospital - Long Island - Urology

Mineola, New York, 11501, United States

NOT YET RECRUITING

Tennessee Oncology - Nashville Centennial Clinic

Nashville, Tennessee, 37203, United States

COMPLETED

The University of Texas MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Virginia Cancer Specialists, PC - Fairfax

Fairfax, Washington, 22031, United States

ACTIVE NOT RECRUITING

UZ Leuven Gasthuisberg - Pneumology Department

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ Delta | Clinical Trial Center - Pneumology

Roeselare, West-Flanders, 8800, Belgium

RECRUITING

Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Rio Grande do Norte, 59040-000, Brazil

RECRUITING

Hospital de Base | Integrated Research Center

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

São Paulo, São Paulo, 05651-901, Brazil

WITHDRAWN

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

ACTIVE NOT RECRUITING

Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech

Wuhan, Hubei, 430023, China

RECRUITING

Hunan Cancer Hospital - Oncology Department

Changsha, Hunan, 410013, China

RECRUITING

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Nanjing, Jiangsu, 210008, China

RECRUITING

Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province

Taizhou, Jiangsu, 317000, China

RECRUITING

Qilu Hosp., Shandong Univ.

Jinan, Shandong, 250012, China

COMPLETED

Shandong University - Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Chest Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

Hangzhou, Zhejiang, 310016, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

UNICANCER - Centre Leon-Berard (CLB) - Medical oncology

Lyon, Auvergne-Rhône-Alpes, 69373, France

RECRUITING

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

Bordeaux, New Aquitaine, 33000, France

RECRUITING

Hopital Nord Laennec - Oncologie medicale thoracique et digestive

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale

Saint-Herblain, Pays de la Loire Region, 44800, France

RECRUITING

AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

WITHDRAWN

Institut Curie - Paris - Oncologie medicale

Paris, Île-de-France Region, 75248, France

RECRUITING

Gustave Roussy - Departement Oncologie-Radiotherapie

Villejuif, Île-de-France Region, 94805, France

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong SAR, 00000, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong SAR, 00000, Hong Kong

RECRUITING

Hong Kong United Oncology Centre

Kowloon, 00000, Hong Kong

WITHDRAWN

Rabin Medical Center | Beilinson Hospital - Nephrology and Hypertension Institute

Petah Tikva, 4941492, Israel

COMPLETED

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

Naples, Campania, 80131, Italy

WITHDRAWN

Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica

Parma, Emilia-Romagna, 43126, Italy

RECRUITING

Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

Rome, Lazio, 00128, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Milan, Lombardy, 20133, Italy

RECRUITING

Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative

Milan, Lombardy, 20141, Italy

COMPLETED

Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

Rozzano, Lombardy, 20089, Italy

RECRUITING

Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

Orbassano, Piedmont, 10043, Italy

RECRUITING

Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia

Verona, 37134, Italy

COMPLETED

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

RECRUITING

Kindai University Hospital

Sakai, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center

Sunto, Shizuoka, 411-8777, Japan

COMPLETED

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Tottori University Hospital

Yonago, Tottori, 683-8504, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

TERMINATED

Radboud University Medical Center | Afdeling Interne Geneeskunde

Nijmegen, Gelderland, 6500 HB, Netherlands

WITHDRAWN

Nederlands Kanker Instituut

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Erasmus University Medical Center | Research Department - Lung Diseases

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

WITHDRAWN

Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland

WITHDRAWN

START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte

Lisbon, 1649-028, Portugal

WITHDRAWN

Hospital Santa Maria | Centro de Investigacao Clinica

Lisbon, 1649-035, Portugal

WITHDRAWN

IPO Porto

Porto, 4200-072, Portugal

RECRUITING

National University Hospital Medical Centre

Singapore, 119074, Singapore

RECRUITING

National Cancer Center Singapore - Oncology Department

Singapore, 168583, Singapore

RECRUITING

Curie Oncology | Mount Elizabeth Novena

Singapore, 329563, Singapore

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea

COMPLETED

St.Vincent's Hospital

Suwon, Gyeonggido, 16247, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System - Oncology Department

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Asan Medical Center | Oncology

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

RECRUITING

Samsung Medical Center - Oncology Department

Seoul, 6351, South Korea

RECRUITING

Institut Catala D'oncologia | Hospitalet | Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitari Dexeus Grupo Quironsalud | Oncologia

Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Vall D Hebron | Oncologia

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz | Oncologia

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Hm Sanchinarro | Oncologia

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen De La Victoria | Oncologia

Málaga, 29010, Spain

WITHDRAWN

Hospital Universitario Y Politecnico La Fe | Oncologia

Valencia, 46026, Spain

RECRUITING

Chung Shan Medical University Hospital

Taichung, 402306, Taiwan

WITHDRAWN

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Chi-Mei Medical Center, Liouyine

Tainan, 73657, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)

Taipei, 23561, Taiwan

WITHDRAWN

Chang Gung Memorial Hospital at Linkou

Taoyuan, 33305, Taiwan

RECRUITING

Related Publications (1)

• Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, Fang Y, Lu S, Dong X, Wu L, Shinno Y, Daniele G, Yang TY, Kim HR, Ruiter G, Zhao J, Novello S, Miao L, Janne PA, Goto K, Ruttinger D, Descamps T, Brase JC, Bao W, Li R, Brega N, Grassi P, Girard N, Tan DS; SOHO-01 Investigators. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Nov 6;393(18):1819-1832. doi: 10.1056/NEJMoa2511065. Epub 2025 Oct 17.

  PMID: 41104928 DERIVED

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 29, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9); TW (7); FR (7); PT (3); BR (3); BE (2); IL (2); ES (7); JP (11); KR (7); CN (14); US (11); NL (3); SG (3); HK (3); PL (2)