A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
NCT ID: NCT05067283
Last Updated: 2026-02-04
Study Results
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Basic Information
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RECRUITING
PHASE1
830 participants
INTERVENTIONAL
2021-12-17
2030-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive daily oral escalating doses of up to 800 mg of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
MK-1084
Oral dose
Arm 2
Participants will receive MK-1084 daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to \~24 months). Treatment with MK-1084 will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
MK-1084
Oral dose
Pembrolizumab
Intravenous infusion of 200 mg
Arm 3
Participants will receive alternate formulation of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
MK-1084
Oral dose
Arm 4
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to \~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.
MK-1084
Oral dose
Pembrolizumab
Intravenous infusion of 200 mg
carboplatin
Per label
pemetrexed
Per label
Arm 5
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.
MK-1084
Oral dose
cetuximab
Per label
Arm 6
Participants will receive MK-1084 daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.
MK-1084
Oral dose
cetuximab
Per label
oxaliplatin
Per label
leucovorin
Per label
5-fluorouracil
Per label
Interventions
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MK-1084
Oral dose
Pembrolizumab
Intravenous infusion of 200 mg
carboplatin
Per label
pemetrexed
Per label
cetuximab
Per label
oxaliplatin
Per label
leucovorin
Per label
5-fluorouracil
Per label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has measurable disease by RECIST 1.1 criteria
* Has adequate organ function
* Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic
* Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
For Arm 2
\- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
For Arm 3
* Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC
* Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample
* Previous treatment failure of at least 1 line of systemic therapy Expansion Group B
* Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
Arm 5 only
* Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
* Previous treatment failure of one or 2 previous line(s) of systemic therapy
Arm 6 only
\- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
Exclusion Criteria
* Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
* Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active infection requiring systemic therapy
* Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
* Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
* Has an active autoimmune disease requiring systemic therapy
* Has not fully recovered from any effects of major surgical procedure without significant detectable infection
* Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
* Has received live or live-attenuated vaccine within 4 weeks of study start
Arm 4 Only
* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \[for example, piroxicam\]) before, during, and for at least 2 days after administration of pemetrexed.
* Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Moffitt Cancer Center ( Site 0261)
Tampa, Florida, United States
START Midwest ( Site 0267)
Grand Rapids, Michigan, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
New York, New York, United States
NEXT Virginia ( Site 0271)
Fairfax, Virginia, United States
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Milwaukee, Wisconsin, United States
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)
La Rioja, , Argentina
Chris O'Brien Lifehouse ( Site 0002)
Camperdown, New South Wales, Australia
Liverpool Hospital-Medical Oncology ( Site 0001)
Liverpool, New South Wales, Australia
Westmead Hospital ( Site 0006)
Westmead, New South Wales, Australia
Monash Health-Oncology Research ( Site 0003)
Clayton, Victoria, Australia
Cross Cancer Institute ( Site 0033)
Edmonton, Alberta, Canada
The Moncton Hospital ( Site 0037)
Moncton, New Brunswick, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
Kingston, Ontario, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
Toronto, Ontario, Canada
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
Santiago, Region M. de Santiago, Chile
FALP-UIDO ( Site 0040)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0042)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0043)
Temuco, Región de la Araucanía, Chile
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
Beijing, Beijing Municipality, China
Fujian Cancer Hospital ( Site 0419)
Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)
Wuhan, Hubei, China
Jilin Cancer Hospital-oncology department ( Site 0412)
Changchun, Jilin, China
Shanghai Chest Hospital-Oncology department ( Site 0410)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 0416)
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
Hangzhou, Zhejiang, China
Odense Universitetshospital-Department of oncology ( Site 0421)
Odense, Region Syddanmark, Denmark
Rambam Health Care Campus-Oncology ( Site 0090)
Haifa, , Israel
Shaare Zedek Medical Center-Oncology ( Site 0092)
Jerusalem, , Israel
Hadassah Medical Center-Oncology ( Site 0094)
Jerusalem, , Israel
Meir Medical Center. ( Site 0091)
Kfar Saba, , Israel
Sheba Medical Center-ONCOLOGY ( Site 0093)
Ramat Gan, , Israel
Humanitas ( Site 0113)
Rozzano, Lombardy, Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)
Siena, Tuscany, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)
Napoli, , Italy
National Cancer Center Hospital East ( Site 0404)
Kashiwa, Chiba, Japan
Kanagawa Cancer Center ( Site 0402)
Yokohama, Kanagawa, Japan
Shizuoka Cancer Center ( Site 0401)
Nakatogari, Shizuoka, Japan
National Cancer Center Hospital ( Site 0403)
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR ( Site 0400)
Koto, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)
Kaunas, Kaunas County, Lithuania
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0120)
Vilnius, , Lithuania
Sarawak General Hospital ( Site 0453)
Kuching, Sarawak, Malaysia
New Zealand Clinical Research (Christchurch) ( Site 0004)
Christchurch, Canterbury, New Zealand
Centro Oncologico de Panama ( Site 0160)
Panama City, , Panama
Centro Hemato Oncológico Paitilla ( Site 0163)
Panama City, , Panama
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
Gdansk, Pomeranian Voivodeship, Poland
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Hospital ( Site 0191)
Seoul, , South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)
Seoul, , South Korea
Clinica Universidad de Navarra ( Site 0213)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)
Barcelona, , Spain
Cantonal Hospital St.Gallen ( Site 0224)
Sankt Gallen, Canton of St. Gallen, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0220)
Bellinzona, Canton Ticino, Switzerland
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
National Cheng Kung University Hospital ( Site 0444)
Tainan, , Taiwan
National Taiwan University Hospital-Oncology ( Site 0443)
Taipei, , Taiwan
Ege University Medicine of Faculty ( Site 0231)
Bornova, İzmir, Turkey (Türkiye)
Erciyes University ( Site 0232)
Talas, Kayseri, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)
Ankara, , Turkey (Türkiye)
Ankara City Hospital-oncology ( Site 0233)
Ankara, , Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 0254)
Cherkasy, Cherkasy Oblast, Ukraine
Communal Non-Commercial Enterprise Prykarpatski Clinical Onc-Chemotherapy department ( Site 0251)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 0255)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Rivne Regional Clinical Hospital ( Site 0257)
Rivne, Rivne Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)
Rivne, Rivne Oblast, Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)
Uzhhorod, Zakarpattia Oblast, Ukraine
Countries
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Central Contacts
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Facility Contacts
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References
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Ma X, Sloman DL, Duggal R, Anderson KD, Ballard JE, Bharathan I, Brynczka C, Gathiaka S, Henderson TJ, Lyons TW, Miller R, Munsell EV, Orth P, Otte RD, Palani A, Rankic DA, Robinson MR, Sather AC, Solban N, Song XS, Wen X, Xu Z, Yang Y, Yang R, Day PJ, Stoeck A, Bennett DJ, Han Y. Discovery of MK-1084: An Orally Bioavailable and Low-Dose KRASG12C Inhibitor. J Med Chem. 2024 Jul 11;67(13):11024-11052. doi: 10.1021/acs.jmedchem.4c00572. Epub 2024 Jun 26.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-1084-001
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2041220034
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501563-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1281-2482
Identifier Type: REGISTRY
Identifier Source: secondary_id
1084-001
Identifier Type: -
Identifier Source: org_study_id
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