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Neoplasm MalignantPhase 2KANDLELIT-014NCT07209111

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

A Phase 2 study testing Calderasib and Cetuximab in people with Neoplasm Malignant, run by Merck Sharp & Dohme LLC at 72 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Malignant
What is being tested?
Calderasib and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
72 sitesin 19 countries
Study dates
4 Dec 2025to 9 Apr 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

72 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

72 sites in 19 countries

China16 sites, 16 recruiting

  • Beijing Cancer hospital ( Site 1318)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 010-88121122

    Recruiting

  • Hunan Cancer Hospital ( Site 1321)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89762321

    Recruiting

  • Hunan Cancer Hospital ( Site 1322)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89762321

    Recruiting

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

    Guangzhou, Guangdong, 510060

    Study Coordinator, 020-87343105

    Recruiting

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

    Guangzhou, Guangdong, 510080

    Study Coordinator, 020-87755766

    Recruiting

  • Zhejiang Cancer Hospital ( Site 1311)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122222

    Recruiting

  • Harbin Medical University Cancer Hospital ( Site 1308)

    Harbin, Heilongjiang, 150000

    Study Coordinator, 0451 8629 8666

    Recruiting

  • Jinan Central Hospital ( Site 1313)

    Jinan, Shandong, 250013

    Study Coordinator, 0531-5586500

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 1312)

    Linhai, Zhejiang, 317000

    Study Coordinator, 0576-85199810

    Recruiting

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

    Nanchang, Jiangxi, 330209

    Study Coordinator, 86079188695051

    Recruiting

  • Jiangsu Province Hospital ( Site 1324)

    Nanjing, Jiangsu, 210029

    Study Coordinator, +8602583718836

    Recruiting

  • Shanghai Chest Hospital ( Site 1300)

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, 021-22200000

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 1325)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-64175590

    Recruiting

  • Zhongshan Hospital,Fudan University ( Site 1301)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-64041990

    Recruiting

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

    Wuhan, Hubei, 430000

    Study Coordinator, +86 027 83262682

    Recruiting

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

    Xiamen, Fujian, 361003

    Study Coordinator, +8613860458889

    Recruiting

Other trials in China

United States6 sites, 6 recruiting

  • Greater Baltimore Medical Center ( Site 1104)

    Baltimore, Maryland, 21204

    Study Coordinator, 443-849-3285

    Recruiting

  • Virginia Cancer Specialists ( Site 1102)

    Fairfax, Virginia, 22031

    Study Coordinator, 703-208-9268

    Recruiting

  • START Midwest ( Site 1103)

    Grand Rapids, Michigan, 49546

    Study Coordinator, 616-389-1808

    Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 1109)

    Las Vegas, Nevada, 89169

    Study Coordinator, 702-952-3400

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 1100)

    New Brunswick, New Jersey, 08903

    Study Coordinator, 732-235-3443

    Recruiting

  • START Mountain Region ( Site 1106)

    West Valley City, Utah, 84119

    Study Coordinator, 210-593-5250

    Recruiting

Other trials in United States

Japan5 sites, 4 recruiting

  • National Cancer Center Hospital ( Site 2000)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Cancer Center Hospital East ( Site 2001)

    Kashiwa, Chiba, 277-8577

    Active, not recruiting

  • Cancer Institute Hospital of JFCR ( Site 2003)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

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

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Kanagawa Cancer Center ( Site 2002)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

Turkey (Türkiye)5 sites, 5 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 2706)

    Adana, 01140

    Study Coordinator, 00904444484

    Recruiting

  • Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)

    Ankara, 06560

    Study Coordinator, +9003122024000

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 2701)

    Ankara, 06800

    Study Coordinator, +90312 552 60 00

    Recruiting

  • Hacettepe Universitesi-oncology hospital ( Site 2700)

    Ankara, 6230

    Study Coordinator, +903123054330

    Recruiting

  • Koc University Hospital ( Site 2704)

    Istanbul, 34010

    Study Coordinator, +908502508250

    Recruiting

Other trials in Turkey (Türkiye)

Chile4 sites, 4 recruiting

  • Fundación Arturo López Pérez ( Site 1200)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224457398

    Recruiting

  • Centro de Oncología de Precisión ( Site 1202)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56225189885

    Recruiting

  • Clinica San Carlos de Apoquindo ( Site 1203)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, 56934331806

    Recruiting

  • Bradfordhill ( Site 1201)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

Other trials in Chile

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d Hebron ( Site 2401)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Hospital Clinic de Barcelona ( Site 2402)

    Barcelona, 08036

    Study Coordinator, +34932274208

    Recruiting

  • Hospital Clinico San Carlos ( Site 2404)

    Madrid, 28040

    Study Coordinator, +34913303000

    Recruiting

  • Hospital Virgen de la Victoria ( Site 2403)

    Málaga, Malaga, 29010

    Study Coordinator, 0034 671 594 566

    Recruiting

Other trials in Spain

Australia3 sites, 3 recruiting

  • Epworth Freemasons ( Site 1004)

    Melbourne, Victoria, 3002

    Study Coordinator, +6194268880

    Recruiting

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

    Randwick, New South Wales, 2031

    Study Coordinator, +61293825131

    Recruiting

  • Westmead Hospital ( Site 1000)

    Westmead, New South Wales, 2145

    Study Coordinator, +61411462609

    Recruiting

Other trials in Australia

Germany3 sites, 3 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604)

    Berlin, 10117

    Study Coordinator, +4930450577041

    Recruiting

  • Universitätsklinikum Jena ( Site 1603)

    Jena, Thuringia, 07747

    Study Coordinator, +4936419324584

    Recruiting

  • Universitätsklinikum Leipzig ( Site 1602)

    Leipzig, Saxony, 04103

    Study Coordinator, +493419712560

    Recruiting

Other trials in Germany

Israel3 sites, 3 recruiting

  • Emek Medical Center ( Site 1800)

    Afula, 1834111

    Study Coordinator, +97246495389

    Recruiting

  • Hadassah Medical Center ( Site 1801)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Sourasky Medical Center ( Site 1802)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Italy3 sites, 3 recruiting

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

    Milan, 20133

    Study Coordinator, 00390223903210

    Recruiting

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

    Roma, 00168

    Study Coordinator, 00390630155202

    Recruiting

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

    Rozzano, Milano, 20089

    Study Coordinator, +390282244559

    Recruiting

Other trials in Italy

Poland3 sites, 3 recruiting

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

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48509098854

    Recruiting

  • MTZ Clinical Research powered by Pratia ( Site 2205)

    Warsaw, Masovian Voivodeship, 02-172

    Study Coordinator, +48225725959

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225463384

    Recruiting

Other trials in Poland

South Korea3 sites, 3 recruiting

  • Seoul National University Hospital ( Site 2301)

    Seoul, 03080

    Study Coordinator, 82-2-2072-1525

    Recruiting

  • Asan Medical Center ( Site 2302)

    Seoul, 05505

    Study Coordinator, +82230101720

    Recruiting

  • Samsung Medical Center ( Site 2300)

    Seoul, 06351

    Study Coordinator, +82234103459

    Recruiting

Other trials in South Korea

Canada2 sites, 2 recruiting

  • Jewish General Hospital-CRU ( Site 2900)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 514-340-8222

    Recruiting

  • The Ottawa Hospital ( Site 2902)

    Ottawa, Ontario, K1H 8L6

    Study Coordinator, 613-737-7700

    Recruiting

Other trials in Canada

Denmark2 sites, 2 recruiting

  • Rigshospitalet ( Site 1403)

    Copenhagen, Capital Region, 2100

    Study Coordinator, +45 35455072

    Recruiting

  • Odense Universitetshospital ( Site 1401)

    Odense, Region Syddanmark, 5000

    Study Coordinator, +45 2963 1327

    Recruiting

Other trials in Denmark

France2 sites, 2 recruiting

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

    Limoges, Haute-Vienne, 87042

    Study Coordinator, +33555087292

    Recruiting

  • Hopital Pitie Salpetriere ( Site 1500)

    Paris, 75013

    Study Coordinator, +33184827695

    Recruiting

Other trials in France

Greece2 sites, 2 recruiting

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

    Athens, Attica, 11527

    Study Coordinator, +302132060954

    Recruiting

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

    Thessaloniki, 57001

    Study Coordinator, +302310400213

    Recruiting

Other trials in Greece

Norway2 sites, 2 recruiting

  • Haukeland universitetssykehus ( Site 2102)

    Bergen, Hordaland, 5021

    Study Coordinator, +4755972890

    Recruiting

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

    Oslo, 0379

    Study Coordinator, +4723026600

    Recruiting

Other trials in Norway

Sweden2 sites, 2 recruiting

  • Sahlgrenska Universitetssjukhuset. ( Site 2502)

    Gothenburg, Västra Götaland County, 413 45

    Study Coordinator, +46313421000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 2501)

    Stockholm, Stockholm County, 171 64

    Study Coordinator, +4612373816

    Recruiting

Other trials in Sweden

United Kingdom2 sites, 2 recruiting

  • Royal Free Hospital ( Site 2801)

    London, Camden, NW3 2QG

    Study Coordinator, +4402077940500

    Recruiting

  • The Christie NHS Foundation Trust ( Site 2803)

    Manchester, M20 4BX

    Study Coordinator, 01614463466

    Recruiting

Other trials in United Kingdom

About this study

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)

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.
Being tested
Calderasib, Cetuximab
Keywords
KRAS, NSCLC, CRC, Tumor-agnostic, Pan Tumor, KRAS G12C
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalderasibDrug

    Also called MK-1084

    Oral administration

  • CetuximabBiological

    Intravenous administration

Study groups in NCT07209111
Study groupRoleWhat they receive
CalderasibExperimentalParticipants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
Receives: Drug: Calderasib
Calderasib + CetuximabExperimentalParticipants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
Receives: Drug: Calderasib; Biological: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 76 months

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 76 months

  3. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 76 months

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 76 months

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 76 months

  3. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death due to any cause. OS will be presented.

    Measured: Up to approximately 76 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start4 Dec 2025
  3. Primary completion9 Apr 2032 (estimated)
  4. Study completion9 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07209111
Sponsor's protocol ID
1084-014
Other IDs
MK-1084-014, U1111-1320-8626, 2025-521737-91-00, jRCT2031250825, 2025
Acronym
KANDLELIT-014
Status last verified
Oct 2026
First submitted
30 Sep 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Calderasib and Cetuximab in people with Neoplasm Malignant, run by Merck Sharp & Dohme LLC at 72 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in China, United States, Japan, Turkey (Türkiye), Chile and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 76 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07209111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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