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RECRUITING Phase 2 ClinicalTrials.gov

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07209111

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Calderasib (Drug)
    Oral administration
  • Cetuximab (Biological)
    Intravenous administration

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment * Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors * Has active infection, other than those permitted per protocol, requiring systemic therapy * Has not adequately recovered from major surgery or has ongoing surgical complications

Conditions

Neoplasm Malignant

Locations

  • 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
  • Westmead Hospital ( Site 1000) — Westmead, New South Wales, Australia
  • Epworth Freemasons ( Site 1004) — Melbourne, Victoria, Australia
  • The Ottawa Hospital ( Site 2902) — Ottawa, Ontario, Canada
  • Jewish General Hospital-CRU ( Site 2900) — Montreal, Quebec, Canada
  • Fundación Arturo López Pérez ( Site 1200) — Santiago, Region M. de Santiago, Chile
  • Centro de Oncología de Precisión ( Site 1202) — Santiago, Region M. de Santiago, Chile
  • Clinica San Carlos de Apoquindo ( Site 1203) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 1201) — Santiago, Region M. de Santiago, Chile
  • 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
  • The first affiliated hospital, Sun Yat-Sen university ( Site 1329) — Guangzhou, Guangdong, China
  • Harbin Medical University Cancer Hospital ( Site 1308) — Harbin, Heilongjiang, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326) — Wuhan, Hubei, China
  • Hunan Cancer Hospital ( Site 1321) — Changsha, Hunan, China
  • Hunan Cancer Hospital ( Site 1322) — Changsha, Hunan, China
  • Jiangsu Province Hospital ( Site 1324) — Nanjing, Jiangsu, China
  • The First Affiliated Hospital of Nanchang University ( Site 1307) — Nanchang, Jiangxi, 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
  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1503) — Limoges, Haute-Vienne, France
  • Hopital Pitie Salpetriere ( Site 1500) — Paris, France
  • Universitätsklinikum Leipzig ( Site 1602) — Leipzig, Saxony, Germany
  • Universitätsklinikum Jena ( Site 1603) — Jena, Thuringia, Germany
  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604) — Berlin, Germany
  • General Hospital of Athens "Laiko" ( Site 1701) — Athens, Attica, Greece
  • 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
  • National Cancer Center Hospital East ( Site 2001) — Kashiwa, Chiba, Japan
  • Kanagawa Cancer Center ( Site 2002) — Yokohama, Kanagawa, Japan
  • National Cancer Center Hospital ( Site 2000) — Chūō, Tokyo, Japan
  • Cancer Institute Hospital of JFCR ( Site 2003) — Koto, Tokyo, Japan
  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2004) — Osaka, Japan
  • 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
  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203) — Koszalin, West Pomeranian 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
  • Adana Medical Park Seyhan Hastanesi ( Site 2706) — Adana, Turkey (Türkiye)
  • Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702) — Ankara, Turkey (Türkiye)
  • Ankara Bilkent Şehir Hastanesi ( Site 2701) — Ankara, Turkey (Türkiye)
  • Hacettepe Universitesi-oncology hospital ( Site 2700) — Ankara, Turkey (Türkiye)
  • Koc University Hospital ( Site 2704) — Istanbul, Turkey (Türkiye)
  • Royal Free Hospital ( Site 2801) — London, Camden, United Kingdom
  • The Christie NHS Foundation Trust ( Site 2803) — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record