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NCT07209111 | RECRUITING | Neoplasm Malignant

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

Merck Sharp & Dohme LLC

Brief 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.

Condition or disease

Neoplasm Malignant

Intervention/treatment

Calderasib

Cetuximab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-12-04
Estimated Primary Completion Date : 2032-04-09
Estimated Study Completion Date : 2032-04-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Location Details

NCT07209111

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Maryland

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, United States, 21204

RECRUITING

United States, road cancer

START Midwest ( Site 1103)

Grand Rapids, road cancer, United States, 49546

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey, United States, 08903

RECRUITING

United States, Utah

START Mountain Region ( Site 1106)

West Valley City, Utah, United States, 84119

RECRUITING

United States, Virginia

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia, United States, 22031

RECRUITING

Australia, New South Wales

Prince of Wales Hospital-Medical Oncology ( Site 1003)

Randwick, New South Wales, Australia, 2031

RECRUITING

China, Beijing Municipality

Beijing Cancer hospital ( Site 1318)

Beijing, Beijing Municipality, China, 100142

RECRUITING

China, Fujian

The First Affiliated Hospital of Xiamen University ( Site 1304)

Xiamen, Fujian, China, 361003

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center ( Site 1303)

Guangzhou, Guangdong, China, 510060

RECRUITING

China, Hubei

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

Wuhan, Hubei, China, 430000

RECRUITING

China, Shandong

Jinan Central Hospital ( Site 1313)

women, Shandong, China, 250013

RECRUITING

China, Shanghai Municipality

Shanghai Chest Hospital ( Site 1300)

Shanghai, Shanghai Municipality, China, 200030

RECRUITING

China, Shanghai Municipality

Fudan University Shanghai Cancer Center ( Site 1325)

Shanghai, Shanghai Municipality, China, 200032

RECRUITING

China, Shanghai Municipality

Zhongshan hospital,F Udan university (site 1301)

Shanghai, Shanghai Municipality, China, 200032

RECRUITING

China, Zhejiang

Zhejiang Cancer Hospital ( Site 1311)

Hangzhou, Zhejiang, China, 310022

RECRUITING

China, Zhejiang

Taizhou hospital of Zhejiang province (site 1312)

Lin Huan, Zhejiang, China, 317000

RECRUITING

Denmark, Capital Region

Rigshospitalet (Site 1403)

Copenhagen, Capital Region, Denmark, 2100

RECRUITING

Denmark, Region Southern Denmark

Odense University Hospital (Site 1401)

Odense, Region Southern Denmark, Denmark, 5000

RECRUITING

Germany, Saxony

Leipzig University Hospital (Site 1602)

Leipzig, Saxony, Germany, 04103

RECRUITING

Germany, Thuringia

Jena University Hospital (Site 1603)

Jena, Thuringia, Germany, 07747

RECRUITING

Greece,

European Interbalkan Medical Center-Oncology Department ( Site 1700)

Thessaloniki, Greece, 57001

RECRUITING

Israel,

Emek Medical Center (Site 1800)

Afula, Israel, 1834111

RECRUITING

Israel,

Hadassah Medical Center ( Site 1801)

Jerusalem, Israel, 9112001

RECRUITING

Israel,

Sourasky Medical Center ( Site 1802)

Tel Aviv, Israel, 6423906

RECRUITING

Italy, Milano

Humanitas-U.O. Clinical Institute of Medical Oncology and Hematology (Site 1902)

Rozzano, Milano, Italy, 20089

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute-Complex Structure Medical Oncology 1 (Site 1900)

Milan, Italy, 20133

RECRUITING

Italy,

Agostino Gemelli University Hospital Foundation IRCCS - Medical Oncology (Site 1901)

Roma, Italy, 00168

RECRUITING

Norway, Hordeland

Haukeland University Hospital ( Site 2102)

Bergen, Hordaland, Norway, 5021

RECRUITING

Norway,

Oslo University Hospital, Radiumhospitalet ( Site 2101)

Oslo, Norway, 0379

RECRUITING

Poland, Masovian Voivodeship

MTZ Clinical Research powered by Pratia ( Site 2205)

Warsaw, Masovian Voivodeship, Poland, 02-172

RECRUITING

Poland, Masovian Voivodeship

National Institute of Oncology Maria Sklodowska-Curie (Site 2200)

Warsaw, Masovian Voivodeship, Poland, 02-781

RECRUITING

South Korea,

Seoul National University Hospital ( Site 2301)

Seoul, South Korea, 03080

RECRUITING

South Korea,

Asan Medical Center ( Site 2302)

Seoul, South Korea, 05505

RECRUITING

South Korea,

Samsung Medical Center ( Site 2300)

Seoul, South Korea, 06351

RECRUITING

Spain, Malaga

Virgen de la Victoria Hospital (Site 2403)

Málaga, Malaga, Spain, 29010

RECRUITING

Spain,

Vall d Hebron University Hospital (Site 2401)

Barcelona, Spain, 08035

RECRUITING

Spain,

Hospital Clinic of Barcelona (Site 2402)

Barcelona, Spain, 08036

RECRUITING

Spain,

San Carlos Clinical Hospital (Site 2404)

Madrid, Spain, 28040

RECRUITING

Sweden, Stockholm County

Karolinska University Hospital Solna ( Site 2501)

Stockholm, Stockholm County, Sweden, 171 64

RECRUITING

Sweden, Västra Götaland County

Sahlgrenska University Hospital. (Site 2502)

Gothenburg, Västra Götaland County, Sweden, 413 45

RECRUITING

Turkey (Türkiye),

Hacettepe University-oncology hospital ( Site 2700)

Ankara, Turkey (Türkiye), 6230