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New hope for Hard-to-Treat cancers: targeted drug combo enters phase 2 trial

NCT ID NCT07209111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    71 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adana Medical Park Seyhan Hastanesi ( Site 2706)

    RECRUITING

    Adana, 01140, Turkey (Türkiye)

  • Ankara Bilkent Şehir Hastanesi ( Site 2701)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center ( Site 2302)

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer hospital ( Site 1318)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradfordhill ( Site 1201)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Cancer Institute Hospital of JFCR ( Site 2003)

    RECRUITING

    Koto, Tokyo, 135-8550, Japan

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1503)

    RECRUITING

    Limoges, Haute-Vienne, 87042, France

  • Centro de Oncología de Precisión ( Site 1202)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604)

    RECRUITING

    Berlin, 10117, Germany

  • Clinica San Carlos de Apoquindo ( Site 1203)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Comprehensive Cancer Centers of Nevada ( Site 1109)

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Emek Medical Center ( Site 1800)

    RECRUITING

    Afula, 1834111, Israel

  • Epworth Freemasons ( Site 1004)

    RECRUITING

    Melbourne, Victoria, 3002, Australia

  • European Interbalkan Medical Center-Oncology Department ( Site 1700)

    RECRUITING

    Thessaloniki, 57001, Greece

  • FALP ( Site 1200)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

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

    RECRUITING

    Milan, 20133, Italy

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

    RECRUITING

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer Center ( Site 1325)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • General Hospital of Athens "Laiko" ( Site 1701)

    RECRUITING

    Athens, Attica, 11527, Greece

  • Greater Baltimore Medical Center ( Site 1104)

    RECRUITING

    Baltimore, Maryland, 21204, United States

  • Hacettepe Universitesi-oncology hospital ( Site 2700)

    RECRUITING

    Ankara, 6230, Turkey (Türkiye)

  • Hadassah Medical Center ( Site 1801)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Harbin Medical University Cancer Hospital ( Site 1308)

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Haukeland universitetssykehus ( Site 2102)

    RECRUITING

    Bergen, Hordaland, 5021, Norway

  • Hopital Pitie Salpetriere ( Site 1500)

    RECRUITING

    Paris, 75013, France

  • Hospital Clinic de Barcelona ( Site 2402)

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos ( Site 2404)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitari Vall d Hebron ( Site 2401)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Virgen de la Victoria ( Site 2403)

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Hunan Cancer Hospital ( Site 1321)

    RECRUITING

    Changsha, Hunan, 410013, China

  • Hunan Cancer Hospital ( Site 1322)

    RECRUITING

    Changsha, Hunan, 410013, China

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

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Jewish General Hospital-CRU ( Site 2900)

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Jiangsu Province Hospital ( Site 1324)

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jinan Central Hospital ( Site 1313)

    RECRUITING

    Jinan, Shandong, 250013, China

  • Kanagawa Cancer Center ( Site 2002)

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Karolinska Universitetssjukhuset Solna ( Site 2501)

    RECRUITING

    Stockholm, Stockholm County, 171 64, Sweden

  • Koc University Hospital ( Site 2704)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • MTZ Clinical Research powered by Pratia ( Site 2205)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-172, Poland

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center Hospital ( Site 2000)

    RECRUITING

    Chūō, Tokyo, 104-0045, Japan

  • Odense Universitetshospital ( Site 1401)

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2004)

    RECRUITING

    Osaka, 541-8567, Japan

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

    RECRUITING

    Oslo, 0379, Norway

  • Prince of Wales Hospital-Medical Oncology ( Site 1003)

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Rigshospitalet ( Site 1403)

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • Royal Free Hospital ( Site 2801)

    RECRUITING

    London, Camden, NW3 2QG, United Kingdom

  • Rutgers Cancer Institute of New Jersey ( Site 1100)

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • START Midwest ( Site 1103)

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region ( Site 1106)

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Sahlgrenska Universitetssjukhuset. ( Site 2502)

    RECRUITING

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Samsung Medical Center ( Site 2300)

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital ( Site 2301)

    RECRUITING

    Seoul, 03080, South Korea

  • Shanghai Chest Hospital ( Site 1300)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Sourasky Medical Center ( Site 1802)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Sun Yat-sen University Cancer Center ( Site 1303)

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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

    RECRUITING

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Taizhou Hospital of Zhejiang Province ( Site 1312)

    RECRUITING

    Linhai, Zhejiang, 317000, China

  • The Christie NHS Foundation Trust ( Site 2803)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Nanchang University ( Site 1307)

    RECRUITING

    Nanchang, Jiangxi, 330209, China

  • The First Affiliated Hospital of Xiamen University ( Site 1304)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The Ottawa Hospital ( Site 2902)

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

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

    RECRUITING

    Guangzhou, Guangdong, 510080, China

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

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Universitätsklinikum Jena ( Site 1603)

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Leipzig ( Site 1602)

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Virginia Cancer Specialists ( Site 1102)

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Westmead Hospital ( Site 1000)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Zhejiang Cancer Hospital ( Site 1311)

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital,Fudan University ( Site 1301)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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Other studies related to the condition(s) this trial covers.