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New drug targets Hard-to-Treat cancers with KRAS mutation

NCT ID NCT05067283

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 4 times

Summary

This early-stage study is testing a new drug called calderasib (MK-1084) in people with advanced solid tumors that have a specific KRAS G12C mutation. The drug is given alone or combined with other cancer treatments. The main goals are to check safety and find the right dose. About 830 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
calderasib (MK-1084) and pembrolizumab, carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, 5-fluorouracil
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific KRAS G12C mutation.
What could go wrong
This is an early phase 1 trial, so safety and effectiveness are not yet proven. The drug may cause side effects or not shrink tumors.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 830 people

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

Started

Dec 2021

Expected to finish

Feb 2030

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: For all participants: * Has measurable disease by RECIST 1.1 criteria * Has adequate organ function * Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic * Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease For Arm 2 \- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% For Arm 3 * Has locally advanced unresectable or metastatic solid-tumor malignancy with histological or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC * Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample * Previous treatment failure of at least 1 line of systemic therapy Expansion Group B * Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation Arm 5 only * Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation * Previous treatment failure of one or 2 previous line(s) of systemic therapy Arm 6 only \- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation Exclusion Criteria: * Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention * Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years * Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection * Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis * Has an active autoimmune disease requiring systemic therapy * Has not fully recovered from any effects of major surgical procedure without significant detectable infection * Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease excluding age-related macular degeneration * Has received live or live-attenuated vaccine within 4 weeks of study start Arm 4 Only * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \[for example, piroxicam\]) before, during, and for at least 2 days after administration of pemetrexed. * Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

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

    67 sites in 20 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

  • Ankara City Hospital-oncology ( Site 0233)

    RECRUITING

    Ankara, 6800, Turkey (Türkiye)

  • Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

  • Bradfordhill ( Site 0042)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Cancer Institute Hospital of JFCR ( Site 0400)

    RECRUITING

    Koto, Tokyo, 135-8550, Japan

  • Cantonal Hospital St.Gallen ( Site 0224)

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Centro Hemato Oncológico Paitilla ( Site 0163)

    COMPLETED

    Panama City, 0832-00752, Panama

  • Centro Oncologico de Panama ( Site 0160)

    RECRUITING

    Panama City, 082410, Panama

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)

    RECRUITING

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Chris O'Brien Lifehouse ( Site 0002)

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Clinica Universidad de Navarra ( Site 0213)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Communal Non-Commercial Enterprise Prykarpatski Clinical Onc-Chemotherapy department ( Site 0251)

    RECRUITING

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

  • Cross Cancer Institute ( Site 0033)

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Ege University Medicine of Faculty ( Site 0231)

    COMPLETED

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Erciyes University ( Site 0232)

    COMPLETED

    Talas, Kayseri, 38039, Turkey (Türkiye)

  • FALP-UIDO ( Site 0040)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fujian Cancer Hospital ( Site 0419)

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center-Oncology ( Site 0094)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28040, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)

    RECRUITING

    Kaunas, Kaunas County, 45433, Lithuania

  • Humanitas ( Site 0113)

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • Instituto Alexander Fleming ( Site 0434)

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)

    RECRUITING

    Naples, 80131, Italy

  • James Lind Centro de Investigacion del Cancer ( Site 0043)

    COMPLETED

    Temuco, Araucania, 4800827, Chile

  • Jilin Cancer Hospital-oncology department ( Site 0412)

    COMPLETED

    Changchun, Jilin, 132000, China

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kanagawa Cancer Center ( Site 0402)

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Laura and Isaac Perlmutter Cancer Center ( Site 0270)

    COMPLETED

    New York, New York, 10016, United States

  • Liverpool Hospital-Medical Oncology ( Site 0001)

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)

    RECRUITING

    Rivne, Rivne Oblast, 33010, Ukraine

  • MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 0254)

    RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Meir Medical Center. ( Site 0091)

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Moffitt Cancer Center ( Site 0261)

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monash Health-Oncology Research ( Site 0003)

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • NEXT Virginia ( Site 0271)

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center Hospital ( Site 0403)

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 0404)

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital ( Site 0444)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Oncology ( Site 0443)

    RECRUITING

    Taipei, 10002, Taiwan

  • New Zealand Clinical Research (Christchurch) ( Site 0004)

    COMPLETED

    Christchurch, Canterbury, 8011, New Zealand

  • Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)

    RECRUITING

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Odense Universitetshospital-Department of oncology ( Site 0421)

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Ospedale Regionale Bellinzona e Valli ( Site 0220)

    RECRUITING

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 0255)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

  • Rambam Health Care Campus-Oncology ( Site 0090)

    RECRUITING

    Haifa, 3109601, Israel

  • Rivne Regional Clinical Hospital ( Site 0257)

    COMPLETED

    Rivne, Rivne Oblast, 33007, Ukraine

  • START Midwest ( Site 0267)

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Parque ( Site 0456)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Sarawak General Hospital ( Site 0453)

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Seoul National University Hospital ( Site 0191)

    RECRUITING

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center-Oncology ( Site 0092)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shanghai Chest Hospital-Oncology department ( Site 0410)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai East Hospital ( Site 0416)

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Sheba Medical Center-ONCOLOGY ( Site 0093)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Shizuoka Cancer Center ( Site 0401)

    RECRUITING

    Nakatogari, Shizuoka, 411-8777, Japan

  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)

    RECRUITING

    Guangzhou, Guangdong, 511400, China

  • The Moncton Hospital ( Site 0037)

    RECRUITING

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)

    RECRUITING

    Wuhan, Hubei, 430048, China

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)

    RECRUITING

    Uzhhorod, Zakarpattia Oblast, 88017, Ukraine

  • Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0120)

    RECRUITING

    Vilnius, LT-08406, Lithuania

  • Westmead Hospital ( Site 0006)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)

    RECRUITING

    Siena, Tuscany, 53100, Italy

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