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NCT07209111PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

12/4/2025

Completion Date

4/9/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Calderasib

BIOLOGICAL

Cetuximab

Interested in This Trial?

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Conditions

Neoplasm Malignant

Locations

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland 21204

United States

START Midwest ( Site 1103)

Grand Rapids, Michigan 49546

United States

Comprehensive Cancer Centers of Nevada ( Site 1109)

Las Vegas, Nevada 89169

United States

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey 08903

United States

START Mountain Region ( Site 1106)

West Valley City, Utah 84119

United States

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia 22031

United States

Prince of Wales Hospital-Medical Oncology ( Site 1003)

Randwick, New South Wales 2031

Australia

Westmead Hospital ( Site 1000)

Westmead, New South Wales 2145

Australia

Epworth Freemasons ( Site 1004)

Melbourne, Victoria 3002

Australia

Jewish General Hospital-CRU ( Site 2900)

Montreal, Quebec H3T 1E2

Canada

FALP ( Site 1200)

Santiago, Region M. de Santiago 7500921

Chile

Centro de Oncología de Precisión ( Site 1202)

Santiago, Region M. de Santiago 7560908

Chile

Clinica San Carlos de Apoquindo ( Site 1203)

Santiago, Region M. de Santiago 7620002

Chile

Bradfordhill ( Site 1201)

Santiago, Region M. de Santiago 8420383

Chile

Beijing Cancer hospital ( Site 1318)

Beijing, Beijing Municipality 100142

China

The First Affiliated Hospital of Xiamen University ( Site 1304)

Xiamen, Fujian 361003

China

Sun Yat-sen University Cancer Center ( Site 1303)

Guangzhou, Guangdong 510060

China

The first affiliated hospital, Sun Yat-Sen university ( Site 1329)

Guangzhou, Guangdong 510080

China

Harbin Medical University Cancer Hospital ( Site 1308)

Harbin, Heilongjiang 150000

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)

Wuhan, Hubei 430000

China

Jiangsu Province Hospital ( Site 1324)

Nanjing, Jiangsu 210029

China

The First Affiliated Hospital of Nanchang University ( Site 1307)

Nanchang, Jiangxi 330209

China

Jinan Central Hospital ( Site 1313)

Jinan, Shandong 250013

China

Shanghai Chest Hospital ( Site 1300)

Shanghai, Shanghai Municipality 200030

China

Fudan University Shanghai Cancer Center ( Site 1325)

Shanghai, Shanghai Municipality 200032

China

Zhongshan Hospital,Fudan University ( Site 1301)

Shanghai, Shanghai Municipality 200032

China

Zhejiang Cancer Hospital ( Site 1311)

Hangzhou, Zhejiang 310022

China

Taizhou Hospital of Zhejiang Province ( Site 1312)

Linhai, Zhejiang 317000

China

Rigshospitalet ( Site 1403)

Copenhagen, Capital Region 2100

Denmark

Odense Universitetshospital ( Site 1401)

Odense, Region Syddanmark 5000

Denmark

Universitätsklinikum Leipzig ( Site 1602)

Leipzig, Saxony 04103

Germany

Universitätsklinikum Jena ( Site 1603)

Jena, Thuringia 07747

Germany

General Hospital of Athens "Laiko" ( Site 1701)

Athens, Attica 11527

Greece

European Interbalkan Medical Center-Oncology Department ( Site 1700)

Thessaloniki, 57001

Greece

Emek Medical Center ( Site 1800)

Afula, 1834111

Israel

Hadassah Medical Center ( Site 1801)

Jerusalem, 9112001

Israel

Sourasky Medical Center ( Site 1802)

Tel Aviv, 6423906

Israel

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)

Rozzano, Milano 20089

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900)

Milan, 20133

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901)

Roma, 00168

Italy

Kanagawa Cancer Center ( Site 2002)

Yokohama, Kanagawa 241-8515

Japan

National Cancer Center Hospital ( Site 2000)

Chūō, Tokyo 104-0045

Japan

Cancer Institute Hospital of JFCR ( Site 2003)

Koto, Tokyo 135-8550

Japan

Haukeland universitetssykehus ( Site 2102)

Bergen, Hordaland 5021

Norway

Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

Oslo, 0379

Norway

MTZ Clinical Research powered by Pratia ( Site 2205)

Warsaw, Masovian Voivodeship 02-172

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200)

Warsaw, Masovian Voivodeship 02-781

Poland

Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203)

Koszalin, West Pomeranian Voivodeship 75-581

Poland

Seoul National University Hospital ( Site 2301)

Seoul, 03080

South Korea

Asan Medical Center ( Site 2302)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 2300)

Seoul, 06351

South Korea

Hospital Virgen de la Victoria ( Site 2403)

Málaga, Malaga 29010

Spain

Hospital Universitari Vall d Hebron ( Site 2401)

Barcelona, 08035

Spain

Hospital Clinic de Barcelona ( Site 2402)

Barcelona, 08036

Spain

Hospital Clinico San Carlos ( Site 2404)

Madrid, 28040

Spain

Karolinska Universitetssjukhuset Solna ( Site 2501)

Stockholm, Stockholm County 171 64

Sweden

Sahlgrenska Universitetssjukhuset. ( Site 2502)

Gothenburg, Västra Götaland County 413 45

Sweden

Adana Medical Park Seyhan Hastanesi ( Site 2706)

Adana, 01140

Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)

Ankara, 06560

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 2701)

Ankara, 06800

Turkey (Türkiye)

Hacettepe Universitesi-oncology hospital ( Site 2700)

Ankara, 6230

Turkey (Türkiye)

Koc University Hospital ( Site 2704)

Istanbul, 34010

Turkey (Türkiye)

Royal Free Hospital ( Site 2801)

London, Camden NW3 2QG

United Kingdom

The Christie NHS Foundation Trust ( Site 2803)

Manchester, M20 4BX

United Kingdom