Clinical trial • Phase II • Oncology
BAY 2927088 for HER2 mutation | Advanced solid tumors
Phase II trial of BAY 2927088 for HER2 mutation | Advanced solid tumors. open-label. 74 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- HER2 mutation | Advanced solid tumors
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-10-2024
- First CTIS Authorization Date
- 13-02-2025
Trial design
open-label Phase II trial across 19 sites in Italy, Denmark, Spain and others.
- Open Label
- Yes
- Biomarker Stratified
- True, HER2 mutation
- Target Sample Size
- 74
Eligibility
Recruits 74 Dataset flag isVulnerablePopulationSelected = true. Inclusion criterion states: "Participant must be ≥18 years of age or over the legal age of consent"; consent is therefore required from the adult participant..
- Vulnerable Population
- Dataset flag isVulnerablePopulationSelected = true. Inclusion criterion states: "Participant must be ≥18 years of age or over the legal age of consent"; consent is therefore required from the adult participant.
Inclusion criteria
- {"criterion_text":"- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)\n- Participant must be ≥18 years of age or over the legal age of consent\n- Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments\n- Documented activating HER2 mutation\n- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria"}
Exclusion criteria
- {"criterion_text":"- Primary diagnosis of non-small cell lung cancer(NSCLC)\n- Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)\n- Active brain metastases\n- Uncontrolled, severe, intercurrent illness"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by blinded independent central review (BICR)"}
Secondary endpoints
- {"endpoint_text":"- Duration of response (DOR) per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"- Time to response (TTR) per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"- ORR per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- Disease control rate (DCR) per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"- DCR ≥12 weeks per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"- Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"- Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- DOR per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- TTR per RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"All-cause mortality measured as time from randomisation/enrolment to death"}
- {"endpoint_text":"- Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity. Number of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Adverse events graded per CTCAE v5.0; counts of TEAEs/TESAEs and discontinuations due to AEs"}
- {"endpoint_text":"- Time to deterioration in EORTC QLQ-C30 physical functioning domain score","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 physical functioning domain; time to predefined deterioration from baseline"}
- {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 physical functioning domain score","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 physical functioning domain score"}
- {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 global health status/QoL"}
Recruitment
- Planned Sample Size
- 74
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent is taken from the participant, who must be ≥18 years or over the legal age of consent. L1 SIS and ICF core documents and related participant materials are provided (documents available in multiple languages including EN, DA, ES, FR, IT as per submitted patient-facing documents). Expecting parents information documents are included in the submission package.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 37
Italy
- Earliest CTIS Part Ii Submission Date
- 13-01-2025
- Latest Decision Or Authorization Date
- 18-02-2025
- Processing Time Days
- 36
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinicogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Sara Cresta
- Principal Investigator Email
- sara.cresta@istitutotumori.mi.it
- Contact Person Name
- Sara Cresta
- Contact Person Email
- sara.cresta@istitutotumori.mi.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- S.C. Oncologia Provinciale
- Principal Investigator Name
- Francesco Caputo
- Principal Investigator Email
- francesco.caputo@ausl.re.it
- Contact Person Name
- Francesco Caputo
- Contact Person Email
- francesco.caputo@ausl.re.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Ginecologia Oncologica Medica
- Principal Investigator Name
- Nicoletta Colombo
- Principal Investigator Email
- nicoletta.colombo@ieo.it
- Contact Person Name
- Nicoletta Colombo
- Contact Person Email
- nicoletta.colombo@ieo.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-01-2025
- Latest Decision Or Authorization Date
- 25-03-2025
- Processing Time Days
- 64
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Rigshospitalet
- Department Name
- Oncology
- Principal Investigator Name
- Martin Højgaard
- Principal Investigator Email
- martin.hoejgaard@regionh.dk
- Contact Person Name
- Martin Højgaard
- Contact Person Email
- martin.hoejgaard@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Oncology
- Principal Investigator Name
- Britt Elmedal Laursen
- Principal Investigator Email
- BRITLA@rm.dk
- Contact Person Name
- Britt Elmedal Laursen
- Contact Person Email
- BRITLA@rm.dk
- Site Name
- Odense University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Line Schmidt Tarpgaard
- Principal Investigator Email
- line.tarpgaard@rsyd.dk
- Contact Person Name
- Line Schmidt Tarpgaard
- Contact Person Email
- line.tarpgaard@rsyd.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 93
- Number Of Sites
- 6
- Number Of Participants
- 9
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Jose Carlos Ruffinelli Rodriguez
- Principal Investigator Email
- jruffinelli@iconcologia.net
- Contact Person Name
- Jose Carlos Ruffinelli Rodriguez
- Contact Person Email
- jruffinelli@iconcologia.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Imanol Martinez Salas
- Principal Investigator Email
- imanol.martinez@quironsalud.es
- Contact Person Name
- Imanol Martinez Salas
- Contact Person Email
- imanol.martinez@quironsalud.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Ignacio Matos Garcia
- Principal Investigator Email
- imatos@unav.es
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- imatos@unav.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology
- Principal Investigator Name
- Alejandro Martinez Bueno
- Principal Investigator Email
- amartinez@oncorosell.com
- Contact Person Name
- Alejandro Martinez Bueno
- Contact Person Email
- amartinez@oncorosell.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Alberto Hernando Calvo
- Principal Investigator Email
- albertohernando@vhio.net
- Contact Person Name
- Alberto Hernando Calvo
- Contact Person Email
- albertohernando@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz (duplicate listing if applicable)
- Department Name
- Oncology
- Principal Investigator Name
- Imanol Martinez Salas
- Principal Investigator Email
- imanol.martinez@quironsalud.es
- Contact Person Name
- Imanol Martinez Salas
- Contact Person Email
- imanol.martinez@quironsalud.es
France
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 56
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie
- Principal Investigator Name
- Antoine HOLLEBECQUE
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine HOLLEBECQUE
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Diego TOSI
- Principal Investigator Email
- diego.tosi@icm.unicancer.fr
- Contact Person Name
- Diego TOSI
- Contact Person Email
- diego.tosi@icm.unicancer.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Benoît YOU
- Principal Investigator Email
- benoit.you@chu-lyon.fr
- Contact Person Name
- Benoît YOU
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Véronique DEBIEN
- Principal Investigator Email
- v.debien@bordeaux.unicancer.fr
- Contact Person Name
- Véronique DEBIEN
- Contact Person Email
- v.debien@bordeaux.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Oncologie
- Principal Investigator Name
- Loic LEBELLEC
- Principal Investigator Email
- l-lebellec@o-lambret.fr
- Contact Person Name
- Loic LEBELLEC
- Contact Person Email
- l-lebellec@o-lambret.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncologie
- Principal Investigator Name
- Jean-Philippe METGES
- Principal Investigator Email
- jean-philippe.metges@chu-brest.fr
- Contact Person Name
- Jean-Philippe METGES
- Contact Person Email
- jean-philippe.metges@chu-brest.fr
Sponsor
Primary sponsor
- Full Name
- Bayer Consumer Care AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- 4g Clinical LLC
- Responsibilities
- sponsorDuties code: 3
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Diagnostic Services LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Q Squared Solutions (Beijing) Co. Ltd.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Guangzhou Burning Rock Dx Co. Ltd.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties code: 15 (Biosample storage)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Life Technologies Clinical Services Lab Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BAY 2927088 Bayer (CM)
- Active Substance
- BAY 2927088
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg BID
- Dose Levels
- 20 mg
- Frequency
- BID
- Maximum Dose
- 40 mg (maxDailyDoseAmount: 40)
- Investigational Product Name
- BAY 2927088 Bayer (CM)
- Active Substance
- SEVABERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg BID
- Dose Levels
- 20 mg
- Frequency
- BID
- Maximum Dose
- 30 mg (maxDailyDoseAmount: 30)
- Investigational Product Name
- BAY 2927088
- Active Substance
- BAY 2927088
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg BID
- Dose Levels
- 20 mg
- Frequency
- BID
- Maximum Dose
- 40 mg (maxDailyDoseAmount: 40)
- Investigational Product Name
- BAY 2927088 Bayer
- Active Substance
- 3-(3-CHLORO-2-METHOXYANILINO)-2-{3-[(2S)-1,4-DIOXAN-2-YLMETHOXY]PYRIDIN-4-YL}-1,5,6,7-TETRAHYDRO-4H-PYRROLO[3,2-C]PYRIDIN-4-ONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg BID
- Dose Levels
- 20 mg
- Frequency
- BID
- Maximum Dose
- 30 mg (maxDailyDoseAmount: 30)
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