Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07209111

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11

150

Participants Needed

55

Research Sites

331 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 55 locations

1

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, United States, 21204

Actively Recruiting

2

START Midwest ( Site 1103)

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

3

Comprehensive Cancer Centers of Nevada ( Site 1109)

Las Vegas, Nevada, United States, 89169

Actively Recruiting

4

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

5

START Mountain Region ( Site 1106)

West Valley City, Utah, United States, 84119

Actively Recruiting

6

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia, United States, 22031

Actively Recruiting

7

Prince of Wales Hospital-Medical Oncology ( Site 1003)

Randwick, New South Wales, Australia, 2031

Actively Recruiting

8

Westmead Hospital ( Site 1000)

Westmead, New South Wales, Australia, 2145

Actively Recruiting

9

Epworth Freemasons ( Site 1004)

Melbourne, Victoria, Australia, 3002

Actively Recruiting

10

FALP ( Site 1200)

Santiago, Region M. de Santiago, Chile, 7500921

Actively Recruiting

11

Centro de Oncología de Precisión ( Site 1202)

Santiago, Region M. de Santiago, Chile, 7560908

Actively Recruiting

12

Clinica San Carlos de Apoquindo ( Site 1203)

Santiago, Region M. de Santiago, Chile, 7620002

Actively Recruiting

13

Bradfordhill ( Site 1201)

Santiago, Region M. de Santiago, Chile, 8420383

Actively Recruiting

14

Beijing Cancer hospital ( Site 1318)

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

15

The First Affiliated Hospital of Xiamen University ( Site 1304)

Xiamen, Fujian, China, 361003

Actively Recruiting

16

Sun Yat-sen University Cancer Center ( Site 1303)

Guangzhou, Guangdong, China, 510060

Actively Recruiting

17

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

Wuhan, Hubei, China, 430000

Actively Recruiting

18

Jiangsu Province Hospital ( Site 1324)

Nanjing, Jiangsu, China, 210029

Actively Recruiting

19

Jinan Central Hospital ( Site 1313)

Jinan, Shandong, China, 250013

Actively Recruiting

20

Shanghai Chest Hospital ( Site 1300)

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

21

Fudan University Shanghai Cancer Center ( Site 1325)

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

22

Zhongshan Hospital,Fudan University ( Site 1301)

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

23

Zhejiang Cancer Hospital ( Site 1311)

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

24

Taizhou Hospital of Zhejiang Province ( Site 1312)

Linhai, Zhejiang, China, 317000

Actively Recruiting

25

Rigshospitalet ( Site 1403)

Copenhagen, Capital Region, Denmark, 2100

Actively Recruiting

26

Odense Universitetshospital ( Site 1401)

Odense, Region Syddanmark, Denmark, 5000

Actively Recruiting

27

Universitätsklinikum Leipzig ( Site 1602)

Leipzig, Saxony, Germany, 04103

Actively Recruiting

28

Universitätsklinikum Jena ( Site 1603)

Jena, Thuringia, Germany, 07747

Actively Recruiting

29

European Interbalkan Medical Center-Oncology Department ( Site 1700)

Thessaloniki, Greece, 57001

Actively Recruiting

30

Emek Medical Center ( Site 1800)

Afula, Israel, 1834111

Actively Recruiting

31

Hadassah Medical Center ( Site 1801)

Jerusalem, Israel, 9112001

Actively Recruiting

32

Sourasky Medical Center ( Site 1802)

Tel Aviv, Israel, 6423906

Actively Recruiting

33

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

Rozzano, Milano, Italy, 20089

Actively Recruiting

34

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

Milan, Italy, 20133

Actively Recruiting

35

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

Roma, Italy, 00168

Actively Recruiting

36

Haukeland universitetssykehus ( Site 2102)

Bergen, Hordaland, Norway, 5021

Actively Recruiting

37

Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

Oslo, Norway, 0379

Actively Recruiting

38

MTZ Clinical Research powered by Pratia ( Site 2205)

Warsaw, Masovian Voivodeship, Poland, 02-172

Actively Recruiting

39

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

Warsaw, Masovian Voivodeship, Poland, 02-781

Actively Recruiting

40

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

Koszalin, West Pomeranian Voivodeship, Poland, 75-581

Actively Recruiting

41

Seoul National University Hospital ( Site 2301)

Seoul, South Korea, 03080

Actively Recruiting

42

Asan Medical Center ( Site 2302)

Seoul, South Korea, 05505

Actively Recruiting

43

Samsung Medical Center ( Site 2300)

Seoul, South Korea, 06351

Actively Recruiting

44

Hospital Virgen de la Victoria ( Site 2403)

Málaga, Malaga, Spain, 29010

Actively Recruiting

45

Hospital Universitari Vall d Hebron ( Site 2401)

Barcelona, Spain, 08035

Actively Recruiting

46

Hospital Clinic de Barcelona ( Site 2402)

Barcelona, Spain, 08036

Actively Recruiting

47

Hospital Clinico San Carlos ( Site 2404)

Madrid, Spain, 28040

Actively Recruiting

48

Karolinska Universitetssjukhuset Solna ( Site 2501)

Stockholm, Stockholm County, Sweden, 171 64

Actively Recruiting

49

Sahlgrenska Universitetssjukhuset. ( Site 2502)

Gothenburg, Västra Götaland County, Sweden, 413 45

Actively Recruiting

50

Adana Medical Park Seyhan Hastanesi ( Site 2706)

Adana, Turkey (Türkiye), 01140

Actively Recruiting

51

Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)

Ankara, Turkey (Türkiye), 06560

Actively Recruiting

52

Hacettepe Universitesi-oncology hospital ( Site 2700)

Ankara, Turkey (Türkiye), 6230

Actively Recruiting

53

Koc University Hospital ( Site 2704)

Istanbul, Turkey (Türkiye), 34010

Actively Recruiting

54

Royal Free Hospital ( Site 2801)

London, Camden, United Kingdom, NW3 2QG

Actively Recruiting

55

The Christie NHS Foundation Trust ( Site 2803)

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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