Evaluating MK-1084 for advanced solid tumors with KRAS mutations
Official title: A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors
Run by Merck Sharp & Dohme LLC · NCT05067283 · Data updated 2026-11-12
This study is testing a new treatment called MK-1084, alone and with other drugs, to see if it helps people with advanced solid tumors that have a specific KRAS mutation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 830 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 75 sites (Tampa, Florida and 74 other locations) |
| Status | Recruiting |
| Started | December 17, 2021 |
| Main results expected | February 25, 2030 |
| Study ends | February 25, 2030 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT05067283 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with advanced solid tumors that have the KRAS G12C mutation and meet specific eligibility criteria.
✕Probably not a fit
Patients without the KRAS G12C mutation or those with other types of advanced solid tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the safety, pharmacokinetics, and efficacy of MK-1084, both alone and in combination with therapies like pembrolizumab, carboplatin, pemetrexed, and cetuximab, in patients with advanced solid tumors harboring the KRAS G12C mutation. Participants must have measurable disease and adequate organ function. The trial aims to determine how well these treatments work in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have the KRAS G12C mutation.
How similar studies have gone: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: For all participants: * 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 histological 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 received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention * 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 excluding age-related macular degeneration * 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
Where it's running
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Moffitt Cancer Center ( Site 0261)
Tampa, Florida, United States Recruiting -
START Midwest ( Site 0267)
Grand Rapids, Michigan, United States Recruiting -
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Hackensack, New Jersey, United States Recruiting -
NEXT Virginia ( Site 0271)
Fairfax, Virginia, United States Recruiting -
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Milwaukee, Wisconsin, United States Recruiting -
Instituto Alexander Fleming ( Site 0434)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina Recruiting
Show 44 more locations
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Sanatorio Parque ( Site 0456)
Rosario, Santa Fe Province, Argentina Recruiting -
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)
La Rioja, Argentina Recruiting -
Chris O'Brien Lifehouse ( Site 0002)
Camperdown, New South Wales, Australia Recruiting -
Liverpool Hospital-Medical Oncology ( Site 0001)
Liverpool, New South Wales, Australia Recruiting -
Westmead Hospital ( Site 0006)
Westmead, New South Wales, Australia Recruiting -
Monash Health-Oncology Research ( Site 0003)
Clayton, Victoria, Australia Recruiting -
Cross Cancer Institute ( Site 0033)
Edmonton, Alberta, Canada Recruiting -
The Moncton Hospital ( Site 0037)
Moncton, New Brunswick, Canada Recruiting -
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
Hamilton, Ontario, Canada Recruiting -
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
Kingston, Ontario, Canada Recruiting -
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
Toronto, Ontario, Canada Recruiting -
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
Santiago, Region M. de Santiago, Chile Recruiting -
FALP-UIDO ( Site 0040)
Santiago, Region M. de Santiago, Chile Recruiting -
Bradfordhill ( Site 0042)
Santiago, Region M. de Santiago, Chile Recruiting -
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
Beijing, Beijing Municipality, China Recruiting -
Fujian Cancer Hospital ( Site 0419)
Fuzhou, Fujian, China Recruiting -
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)
Guangzhou, Guangdong, China Recruiting -
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
Guangzhou, Guangdong, China Recruiting -
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)
Wuhan, Hubei, China Recruiting -
Shanghai Chest Hospital-Oncology department ( Site 0410)
Shanghai, Shanghai Municipality, China Recruiting -
Shanghai East Hospital ( Site 0416)
Shanghai, Shanghai Municipality, China Recruiting -
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
Hangzhou, Zhejiang, China Recruiting -
Odense Universitetshospital-Department of oncology ( Site 0421)
Odense, Region Syddanmark, Denmark Recruiting -
Rambam Health Care Campus-Oncology ( Site 0090)
Haifa, Israel Recruiting -
Shaare Zedek Medical Center-Oncology ( Site 0092)
Jerusalem, Israel Recruiting -
Hadassah Medical Center-Oncology ( Site 0094)
Jerusalem, Israel Recruiting -
Meir Medical Center. ( Site 0091)
Kfar Saba, Israel Recruiting -
Sheba Medical Center-ONCOLOGY ( Site 0093)
Ramat Gan, Israel Recruiting -
Humanitas ( Site 0113)
Rozzano, Lombardy, Italy Recruiting -
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)
Siena, Tuscany, Italy Recruiting -
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)
Naples, Italy Recruiting -
National Cancer Center Hospital East ( Site 0404)
Kashiwa, Chiba, Japan Recruiting -
Kanagawa Cancer Center ( Site 0402)
Yokohama, Kanagawa, Japan Recruiting -
Shizuoka Cancer Center ( Site 0401)
Nakatogari, Shizuoka, Japan Recruiting -
National Cancer Center Hospital ( Site 0403)
Chuo-ku, Tokyo, Japan Recruiting -
Cancer Institute Hospital of JFCR ( Site 0400)
Koto, Tokyo, Japan Recruiting -
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)
Kaunas, Kaunas County, Lithuania Recruiting -
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0120)
Vilnius, Lithuania Recruiting -
Sarawak General Hospital ( Site 0453)
Kuching, Sarawak, Malaysia Recruiting -
Centro Oncologico de Panama ( Site 0160)
Panama City, Panama Recruiting -
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)
Poznan, Greater Poland Voivodeship, Poland Recruiting -
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)
Warsaw, Masovian Voivodeship, Poland Recruiting -
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
Gdansk, Pomeranian Voivodeship, Poland Recruiting -
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)
Koszalin, West Pomeranian Voivodeship, Poland Recruiting
+25 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.