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

NCT ID NCT05067283

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

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 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.

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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

Contacts and locations

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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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