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A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: * How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
Official title: A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-12-04
Completion Date
2032-04-09
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Calderasib
Oral administration
Cetuximab
Intravenous administration
Locations (43)
Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, United States
START Midwest ( Site 1103)
Grand Rapids, Michigan, United States
Comprehensive Cancer Centers of Nevada ( Site 1109)
Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey, United States
START Mountain Region ( Site 1106)
West Valley City, Utah, United States
Virginia Cancer Specialists ( Site 1102)
Fairfax, Virginia, United States
Prince of Wales Hospital-Medical Oncology ( Site 1003)
Randwick, New South Wales, Australia
Beijing Cancer hospital ( Site 1318)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 1304)
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center ( Site 1303)
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)
Wuhan, Hubei, China
Jinan Central Hospital ( Site 1313)
Jinan, Shandong, China
Shanghai Chest Hospital ( Site 1300)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 1325)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University ( Site 1301)
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital ( Site 1311)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 1312)
Linhai, Zhejiang, China
Rigshospitalet ( Site 1403)
Copenhagen, Capital Region, Denmark
Odense Universitetshospital ( Site 1401)
Odense, Region Syddanmark, Denmark
Universitätsklinikum Leipzig ( Site 1602)
Leipzig, Saxony, Germany
Universitätsklinikum Jena ( Site 1603)
Jena, Thuringia, Germany
European Interbalkan Medical Center-Oncology Department ( Site 1700)
Thessaloniki, Greece
Emek Medical Center ( Site 1800)
Afula, Israel
Hadassah Medical Center ( Site 1801)
Jerusalem, Israel
Sourasky Medical Center ( Site 1802)
Tel Aviv, Israel
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)
Rozzano, Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900)
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901)
Roma, Italy
Haukeland universitetssykehus ( Site 2102)
Bergen, Hordaland, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2101)
Oslo, Norway
MTZ Clinical Research powered by Pratia ( Site 2205)
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200)
Warsaw, Masovian Voivodeship, Poland
Seoul National University Hospital ( Site 2301)
Seoul, South Korea
Asan Medical Center ( Site 2302)
Seoul, South Korea
Samsung Medical Center ( Site 2300)
Seoul, South Korea
Hospital Virgen de la Victoria ( Site 2403)
Málaga, Malaga, Spain
Hospital Universitari Vall d Hebron ( Site 2401)
Barcelona, Spain
Hospital Clinic de Barcelona ( Site 2402)
Barcelona, Spain
Hospital Clinico San Carlos ( Site 2404)
Madrid, Spain
Karolinska Universitetssjukhuset Solna ( Site 2501)
Stockholm, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset. ( Site 2502)
Gothenburg, Västra Götaland County, Sweden
Hacettepe Universitesi-oncology hospital ( Site 2700)
Ankara, Turkey (Türkiye)
The Christie NHS Foundation Trust ( Site 2803)
Manchester, United Kingdom