New hope for Hard-to-Treat cancers: targeted drug combo enters phase 2 trial
NCT ID NCT07209111
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 12 times
Summary
This phase 2 trial is testing a drug called calderasib (MK-1084), given alone or with cetuximab, in 150 people with advanced solid tumors that have a specific KRAS G12C mutation. The goal is to see if the cancer shrinks or disappears and to check for side effects. Participants must have tumors that are not colorectal cancer and have progressed after standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- calderasib (also known as MK-1084) and cetuximab
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced solid tumors that have a specific KRAS G12C mutation.
- What could go wrong
- This is a phase 2 trial with only 150 participants, so results are still early. The drug may not work for all tumor types, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
71 sites in 19 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Adana Medical Park Seyhan Hastanesi ( Site 2706)
RECRUITINGAdana, 01140, Turkey (Türkiye)
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Ankara Bilkent Şehir Hastanesi ( Site 2701)
RECRUITINGAnkara, 06800, Turkey (Türkiye)
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Asan Medical Center ( Site 2302)
RECRUITINGSeoul, 05505, South Korea
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Beijing Cancer hospital ( Site 1318)
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Bradfordhill ( Site 1201)
RECRUITINGSantiago, Region M. de Santiago, 8420383, Chile
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Cancer Institute Hospital of JFCR ( Site 2003)
RECRUITINGKoto, Tokyo, 135-8550, Japan
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Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1503)
RECRUITINGLimoges, Haute-Vienne, 87042, France
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Centro de Oncología de Precisión ( Site 1202)
RECRUITINGSantiago, Region M. de Santiago, 7560908, Chile
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Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604)
RECRUITINGBerlin, 10117, Germany
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Clinica San Carlos de Apoquindo ( Site 1203)
RECRUITINGSantiago, Region M. de Santiago, 7620002, Chile
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Comprehensive Cancer Centers of Nevada ( Site 1109)
RECRUITINGLas Vegas, Nevada, 89169, United States
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Emek Medical Center ( Site 1800)
RECRUITINGAfula, 1834111, Israel
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Epworth Freemasons ( Site 1004)
RECRUITINGMelbourne, Victoria, 3002, Australia
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European Interbalkan Medical Center-Oncology Department ( Site 1700)
RECRUITINGThessaloniki, 57001, Greece
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FALP ( Site 1200)
RECRUITINGSantiago, Region M. de Santiago, 7500921, Chile
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Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900)
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901)
RECRUITINGRoma, 00168, Italy
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Fudan University Shanghai Cancer Center ( Site 1325)
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)
RECRUITINGAnkara, 06560, Turkey (Türkiye)
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General Hospital of Athens "Laiko" ( Site 1701)
RECRUITINGAthens, Attica, 11527, Greece
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Greater Baltimore Medical Center ( Site 1104)
RECRUITINGBaltimore, Maryland, 21204, United States
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Hacettepe Universitesi-oncology hospital ( Site 2700)
RECRUITINGAnkara, 6230, Turkey (Türkiye)
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Hadassah Medical Center ( Site 1801)
RECRUITINGJerusalem, 9112001, Israel
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Harbin Medical University Cancer Hospital ( Site 1308)
RECRUITINGHarbin, Heilongjiang, 150000, China
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Haukeland universitetssykehus ( Site 2102)
RECRUITINGBergen, Hordaland, 5021, Norway
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Hopital Pitie Salpetriere ( Site 1500)
RECRUITINGParis, 75013, France
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Hospital Clinic de Barcelona ( Site 2402)
RECRUITINGBarcelona, 08036, Spain
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Hospital Clinico San Carlos ( Site 2404)
RECRUITINGMadrid, 28040, Spain
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Hospital Universitari Vall d Hebron ( Site 2401)
RECRUITINGBarcelona, 08035, Spain
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Hospital Virgen de la Victoria ( Site 2403)
RECRUITINGMálaga, Malaga, 29010, Spain
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Hunan Cancer Hospital ( Site 1321)
RECRUITINGChangsha, Hunan, 410013, China
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Hunan Cancer Hospital ( Site 1322)
RECRUITINGChangsha, Hunan, 410013, China
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Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)
RECRUITINGRozzano, Milano, 20089, Italy
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Jewish General Hospital-CRU ( Site 2900)
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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Jiangsu Province Hospital ( Site 1324)
RECRUITINGNanjing, Jiangsu, 210029, China
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Jinan Central Hospital ( Site 1313)
RECRUITINGJinan, Shandong, 250013, China
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Kanagawa Cancer Center ( Site 2002)
RECRUITINGYokohama, Kanagawa, 241-8515, Japan
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Karolinska Universitetssjukhuset Solna ( Site 2501)
RECRUITINGStockholm, Stockholm County, 171 64, Sweden
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Koc University Hospital ( Site 2704)
RECRUITINGIstanbul, 34010, Turkey (Türkiye)
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MTZ Clinical Research powered by Pratia ( Site 2205)
RECRUITINGWarsaw, Masovian Voivodeship, 02-172, Poland
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200)
RECRUITINGWarsaw, Masovian Voivodeship, 02-781, Poland
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National Cancer Center Hospital ( Site 2000)
RECRUITINGChūō, Tokyo, 104-0045, Japan
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Odense Universitetshospital ( Site 1401)
RECRUITINGOdense, Region Syddanmark, 5000, Denmark
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Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2004)
RECRUITINGOsaka, 541-8567, Japan
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Oslo universitetssykehus, Radiumhospitalet ( Site 2101)
RECRUITINGOslo, 0379, Norway
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Prince of Wales Hospital-Medical Oncology ( Site 1003)
RECRUITINGRandwick, New South Wales, 2031, Australia
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Rigshospitalet ( Site 1403)
RECRUITINGCopenhagen, Capital Region, 2100, Denmark
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Royal Free Hospital ( Site 2801)
RECRUITINGLondon, Camden, NW3 2QG, United Kingdom
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Rutgers Cancer Institute of New Jersey ( Site 1100)
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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START Midwest ( Site 1103)
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START Mountain Region ( Site 1106)
RECRUITINGWest Valley City, Utah, 84119, United States
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Sahlgrenska Universitetssjukhuset. ( Site 2502)
RECRUITINGGothenburg, Västra Götaland County, 413 45, Sweden
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Samsung Medical Center ( Site 2300)
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital ( Site 2301)
RECRUITINGSeoul, 03080, South Korea
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Shanghai Chest Hospital ( Site 1300)
RECRUITINGShanghai, Shanghai Municipality, 200030, China
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Sourasky Medical Center ( Site 1802)
RECRUITINGTel Aviv, 6423906, Israel
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Sun Yat-sen University Cancer Center ( Site 1303)
RECRUITINGGuangzhou, Guangdong, 510060, China
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Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203)
RECRUITINGKoszalin, West Pomeranian Voivodeship, 75-581, Poland
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Taizhou Hospital of Zhejiang Province ( Site 1312)
RECRUITINGLinhai, Zhejiang, 317000, China
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The Christie NHS Foundation Trust ( Site 2803)
RECRUITINGManchester, M20 4BX, United Kingdom
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The First Affiliated Hospital of Nanchang University ( Site 1307)
RECRUITINGNanchang, Jiangxi, 330209, China
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The First Affiliated Hospital of Xiamen University ( Site 1304)
RECRUITINGXiamen, Fujian, 361003, China
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The Ottawa Hospital ( Site 2902)
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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The first affiliated hospital, Sun Yat-Sen university ( Site 1329)
RECRUITINGGuangzhou, Guangdong, 510080, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)
RECRUITINGWuhan, Hubei, 430000, China
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Universitätsklinikum Jena ( Site 1603)
RECRUITINGJena, Thuringia, 07747, Germany
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Universitätsklinikum Leipzig ( Site 1602)
RECRUITINGLeipzig, Saxony, 04103, Germany
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Virginia Cancer Specialists ( Site 1102)
RECRUITINGFairfax, Virginia, 22031, United States
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Westmead Hospital ( Site 1000)
RECRUITINGWestmead, New South Wales, 2145, Australia
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Zhejiang Cancer Hospital ( Site 1311)
RECRUITINGHangzhou, Zhejiang, 310022, China
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Zhongshan Hospital,Fudan University ( Site 1301)
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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