Clinical trial • Phase II • Oncology
MK-1084 for KRAS G12C-mutant advanced solid tumors | Neoplasm malignant with KRAS G12C mutation
Phase II trial of MK-1084 for KRAS G12C-mutant advanced solid tumors | Neoplasm malignant with KRAS G12C mutation.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- KRAS G12C-mutant advanced solid tumors | Neoplasm malignant with KRAS G12C mutation
- Trial Stage
- Phase II
- Drug Modality
- Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-07-2025
- First CTIS Authorization Date
- 12-11-2025
Trial design
open-label, mk-1084 plus cetuximab versus mk-1084 monotherapy; doses and schedules not specified in the provided record-controlled Phase II trial in Germany, France, Spain and others.
- Open Label
- Yes
- Comparator
- MK-1084 plus cetuximab versus MK-1084 monotherapy; doses and schedules not specified in the provided record
- Biomarker Stratified
- True (KRAS G12C mutation - participants selected for presence of KRAS G12C)
- Target Sample Size
- 97
Eligibility
Recruits 97 No vulnerable population selected (isVulnerablePopulationSelected: false)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment\n- Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation"}
Exclusion criteria
- {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors\n- Has active infection, other than those permitted per protocol, requiring systemic therapy\n- Has not adequately recovered from major surgery or has ongoing surgical complications"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) (as stated in main objectives)"}
- {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants who experience one or more adverse events (AE) as reported during the study (no further measurement details provided)"}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention due to an adverse event (AE) (no further measurement details provided)"}
Secondary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (OS) as stated (time to death); specific assessment details not provided"}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by blinded independent central review (BICR) (as stated in secondary objectives)"}
- {"endpoint_text":"- Progression-free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) (as stated in secondary objectives)"}
Recruitment
- Planned Sample Size
- 97
- Recruitment Window Months
- 75
- Consent Approach
- Main informed consent forms and optional consent modules are provided (country-specific L1_ICF_Main consent documents are listed). Optional consent modules referenced in documents include limited screening consent, pregnancy follow-up, pregnant partner, data privacy and optional sample consents. Country-specific ICFs are present for multiple countries (e.g., DEU, FRA, ESP, ITA, GRC, NOR, DNK, POL, SWE) as indicated by the listed documents.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 74
Germany
- Earliest CTIS Part Ii Submission Date
- 27-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 17
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Universitäres Krebszentrum Leipzig
- Contact Person Name
- Gertraut Stocker
- Contact Person Email
- studienzentrale.uccl@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Abteilung für Hämatologie und Internistische Onkologie der KIM II
- Contact Person Name
- Jakob Hammersen
- Contact Person Email
- jakob.hammeren@med.uni-jena.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Onkologische Portalambulanz
- Contact Person Name
- Arndt Stahler
- Contact Person Email
- haemaonko-studienccm@charite.de
France
- Earliest CTIS Part Ii Submission Date
- 29-09-2025
- Latest Decision Or Authorization Date
- 14-11-2025
- Processing Time Days
- 46
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncologie Medicale
- Contact Person Name
- Baptiste ABBAR
- Contact Person Email
- baptiste.abbar@aphp.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Oncologie Medicale
- Contact Person Name
- Frederic THUILLIER
- Contact Person Email
- frederic.thuillier@chu-limoges.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 06-10-2025
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 42
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Contact Person Name
- Jorge Bartolomé Arcilla
- Contact Person Email
- jorge.bartolome@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- fasestempranas@ibima.eu
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- NEXT Oncology Phase I unit - IOB Hospital Quironsalud Barcelona
- Contact Person Name
- Omar Saavedra Santa Gadea
- Contact Person Email
- osaavedra@nextoncology.eu
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Ivan Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Italy
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 14-11-2025
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Unità Operativa di Oncologia ed Ematologia
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@hunimed.eu
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. di Oncologia Medica
- Contact Person Name
- Giampaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
Greece
- Earliest CTIS Part Ii Submission Date
- 04-08-2025
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 100
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- International Oncology Center- Oncology Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- University of Athens, Oncology Department
- Contact Person Name
- Helen Gogas
- Contact Person Email
- helgogas@gmail.com
Norway
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Tormod Kyrre Guren
- Contact Person Email
- uxtour@ous-hf.no
- Site Name
- Helse Bergen HF
- Department Name
- Department of Oncology
- Contact Person Name
- Cornelia Schuster
- Contact Person Email
- cornelia.schuster@helse-bergen.no
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Jon Henriksen
- Contact Person Email
- jon.henriksen@rsyd.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 15-11-2025
- Processing Time Days
- 39
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddział Badań Wczesnych Faz
- Contact Person Name
- Iwona Ługowska
- Contact Person Email
- obwf@nio.gov.pl
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- sekretariat.odch@swk.med.pl
- Site Name
- Pratia S.A.
- Department Name
- MTZ Clinical Research Powered By Pratia
- Contact Person Name
- Krzysztof Woźniak
- Contact Person Email
- info@pratia.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
- Contact Person Name
- Łukasz Jędrzejewski
- Contact Person Email
- obkwf@uck.gda.pl
Sweden
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 33
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Onkologikliniken
- Contact Person Name
- Edvard Abel
- Contact Person Email
- edvard.abel@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- Fas 1-enheten Solna, Centrum för Kliniska Cancerstudier (CKC), Tema Cancer
- Contact Person Name
- Maximilian Kordes
- Contact Person Email
- maximilian.kordes@regionstockholm.se
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Almac Clinical Technologies LLC
- Name
- Almac Diagnostic Services LLC
- Name
- PPD Global Central Labs
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Diagnostic Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-1084
- Active Substance
- MK-1084
- Modality
- Small molecule
- Routes Of Administration
- OTHER USE
- Route
- OTHER USE
- Authorisation Status
- prodAuthStatus=1
- Investigational Product Name
- CETUXIMAB
- Active Substance
- CETUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus=2
- Maximum Dose
- maxDailyDoseAmount 500 mg/m2; maxTotalDoseAmount 84000 (units as provided)
- Combination Treatment
- Yes
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