RecruitingPhase III🇵🇱 PolandEN originalColorectal cancerMetastatic / advanced

A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn: * About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony histologicznie (badaniem mikroskopowym) zaawansowany lub przerzutowy rak jelita grubego, którego nie można operacyjnie usunąć
  • Obecność mutacji KRAS G12C w komórkach nowotworu
  • W części 2 badania: brak wcześniejszego systemowego leczenia tego typu raka (dopuszczalne 1-2 cykle FOLFOX lub 1 cykl CAPOX)
  • Pacjenci z HIV mogą uczestniczyć, jeśli wirus jest kontrolowany lekami
  • Pacjenci z wirusem hepatitis B mogą uczestniczyć, jeśli otrzymują leczenie i wirus jest niewykrywalny
  • Pacjenci z przebytą wirusową zapaleniem wątroby typu C mogą uczestniczyć, jeśli wirus jest niewykrywalny

✗ Disqualifies

  • Aktywne zapalenie jelit wymagające leków immunosupresyjnych lub wcześniejsze przewlekłe choroby jelit (np. choroba Crohna, wrzodziejące zapalenie jelit)
  • Niekontrolowana choroba serca lub naczyniowa mózgu
  • Genetyczny niedobór enzymu DPD (zaburzenie metabolizmu niektórych chemioterapii)
  • Pacjenci z HIV i wywiadem mięsaka Kaposiego lub choroby Castelmana
  • Poprzednie systemowe leczenie przeciwnowotworowe w ciągu 4 tygodni przed włączeniem do badania
  • Warunki medyczne, które mogą uniemożliwić bezpieczne podanie bevacizumabu
  • Inny aktywny nowotwór poza rakiem jelita grubego

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (217)

Los Angeles Hematology Oncology Medical Group ( Site 0084)

Los Angeles, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0088)

Santa Monica, United States

University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)

Fort Collins, United States

Rocky Mountain Cancer Centers (RMCC) ( Site 8000)

Lone Tree, United States

Florida Cancer Specialists - South ( Site 7002)

Fort Myers, United States

Orlando Health Cancer Institute ( Site 0065)

Orlando, United States

Florida Cancer Specialists - North ( Site 7001)

St. Petersburg, United States

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, United States

Saint Alphonsus Regional Medical Center ( Site 0085)

Boise, United States

Accellacare of Duly ( Site 2015)

Lisle, United States

University of Iowa ( Site 0074)

Iowa City, United States

University of Kentucky ( Site 0055)

Lexington, United States

Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

Louisville, United States

Greater Baltimore Medical Center ( Site 0068)

Baltimore, United States

Hattiesburg Clinic ( Site 0064)

Hattiesburg, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)

Billings, United States

University Of Nebraska Medical Center ( Site 0078)

Omaha, United States

Renown Regional Medical Center ( Site 0056)

Reno, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)

Hackensack, United States

Atlantic Health System ( Site 0093)

Summit, United States

San Juan Oncology Associates, P.C ( Site 2011)

Farmington, United States

Ellis Hospital ( Site 0098)

Schenectady, United States

Miami Valley Hospital South ( Site 0075)

Centerville, United States

Texas Oncology - DFW ( Site 8002)

Dallas, United States

UT Southwestern Medical Center ( Site 0059)

Dallas, United States

Texas Oncology - Northeast Texas ( Site 8001)

Denison, United States

Texas Oncology - San Antonio ( Site 8004)

San Antonio, United States

Community Cancer Trials of Utah ( Site 0086)

Ogden, United States

University of Virginia ( Site 0080)

Charlottesville, United States

Virginia Cancer Specialists, PC ( Site 0069)

Fairfax, United States

Fred Hutchinson Cancer Center ( Site 0076)

Seattle, United States

West Virginia University ( Site 2017)

Morgantown, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110)

Berazategui, Argentina

Hospital Italiano de Buenos Aires ( Site 0102)

Ciudad Autonoma de Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 0101)

Mar del Plata, Argentina

Fundacion Estudios Clinicos ( Site 0105)

Rosario, Argentina

Sanatorio Parque ( Site 0103)

Rosario, Argentina

Hospital Privado Universitario de Córdoba ( Site 0108)

Córdoba, Argentina

Wollongong Hospital ( Site 0453)

Wollongong, Australia

Sunshine Coast University Hospital ( Site 0451)

Birtinya, Australia

Monash Health ( Site 0454)

Clayton, Australia

Western Health-Sunshine & Footscray Hospitals ( Site 0450)

St Albans, Australia

Hospital de Câncer de Recife ( Site 0158)

Recife, Brazil

Hospital de Caridade de Ijuí ( Site 0150)

Ijuí, Brazil

Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)

Passo Fundo, Brazil

Hospital Nossa Senhora da Conceição ( Site 0156)

Porto Alegre, Brazil

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)

Florianópolis, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)

Barretos, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)

São José do Rio Preto, Brazil

COE Ensino e Pesquisa ( Site 0151)

São José dos Campos, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)

São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)

São Paulo, Brazil

Cancercare Manitoba ( Site 0009)

Winnipeg, Canada

Moncton Hospital - Horizon Health Network ( Site 0011)

Moncton, Canada

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Canada

CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)

Chicoutimi, Canada

Jewish General Hospital ( Site 0006)

Montreal, Canada

CIDO SpA ( Site 0212)

Temuco, Chile

Clínica Puerto Montt ( Site 0206)

Port Montt, Chile

Oncocentro Valdivia ( Site 0204)

Valdivia, Chile

Fundacion Arturo Lopez Perez ( Site 0201)

Santiago, Chile

Centro de Oncología de Precisión ( Site 0207)

Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 0211)

Santiago, Chile

CECIM ( Site 0210)

Santiago, Chile

Bradfordhill ( Site 0200)

Santiago, Chile

Clínica RedSalud Vitacura ( Site 0202)

Vitacura, Chile

ONCOCENTRO APYS ( Site 0203)

Viña del Mar, Chile

Anhui Provincial Cancer Hospital ( Site 0803)

Hefei, China

The Second Affiliated Hospital of Anhui Medical University ( Site 0813)

Hefei, China

Peking Union Medical College Hospital ( Site 0824)

Beijing, China

Peking University First Hospital(Daxing Area) ( Site 0838)

Beijing, China

Chongqing University Cancer Hospital ( Site 0808)

Chongqing, China

Chongqing University Three Gorges Hospital ( Site 0837)

Wanzhou, China

Fujian Cancer Hospital ( Site 0807)

Fuzhou, China

The First Affiliated Hospital of Xiamen University ( Site 0806)

Xiamen, China

Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)

Xiamen, China

Sun Yat-Sen University Cancer Center ( Site 0800)

Guangzhou, China

Southern Medical University Nanfang Hospital ( Site 0812)

Guangzhou, China

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)

Guangzhou, China

The University of Hong Kong - Shenzhen Hospital ( Site 1903)

Shenzhen, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)

Nanning, China

Harbin Medical University Cancer Hospital ( Site 0847)

Harbin, China

Henan Cancer Hospital ( Site 0822)

Zhengzhou, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)

Wuhan, China

Hubei Cancer Hospital ( Site 0814)

Wuhan, China

Hunan Cancer Hospital ( Site 0815)

Changsha, China

The Third Xiangya Hospital of Central South University ( Site 0834)

Changsha, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)

Nanjing, China

The First Affiliated Hospital of Nanchang University ( Site 0826)

Nanchang, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0802)

Xi'an, China

Jinan Central Hospital ( Site 0817)

Jinan, China

Zhongshan Hospital of Fudan University ( Site 0832)

Shanghai, China

Fudan University Shanghai Cancer Center ( Site 0816)

Shanghai, China

Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 1906)

Shanghai, China

First Affiliated Hospital of Shanxi Medical University ( Site 0843)

Taiyuan, China

West China Hospital, Sichuan University ( Site 0805)

Chengdu, China

Sichuan Cancer hospital. ( Site 0831)

Chengdu, China

First Affiliated Hospital of Kunming Medical University ( Site 0845)

Kunming, China

The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)

Hangzhou, China

Zhejiang Cancer Hospital ( Site 0821)

Hangzhou, China

The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)

Wenzhou, China

Hospital Universitario San Ignacio ( Site 0254)

Bogota, Colombia

IMAT S.A.S ( Site 0252)

Montería, Colombia

Oncologos Del Occidente ( Site 0255)

Pereira, Colombia

Tampere University Hospital ( Site 1001)

Tampere, Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)

Helsinki, Finland

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)

Nice, France

Centre François Baclesse ( Site 1061)

Caen, France

CHU Rangueil ( Site 1063)

Toulouse, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)

Limoges, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)

Vandœuvre-lès-Nancy, France

Institut Jean Godinot ( Site 1054)

Reims, France

Institut de Cancérologie de l'Ouest ( Site 1062)

Angers, France

CHU Charles Nicolle ( Site 1066)

Rouen, France

Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)

Avignon, France

Hôpital Saint Antoine ( Site 1051)

Paris, France

Hôpital Européen Georges Pompidou ( Site 1050)

Paris, France

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1104)

Essen, Germany

Katholisches Marienkrankenhaus gGmbH ( Site 1103)

Hamburg, Germany

Asklepios Klinik Altona ( Site 1100)

Hamburg, Germany

Prince of Wales Hospital. ( Site 0500)

Hong Kong, Hong Kong

Queen Mary Hospital ( Site 0501)

Hong Kong, Hong Kong

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)

Pécs, Hungary

Rambam Health Care Campus ( Site 1253)

Haifa, Israel

Hadassah Medical Center ( Site 1252)

Jerusalem, Israel

Rabin Medical Center ( Site 1251)

Petah Tikva, Israel

Sheba Medical Center ( Site 1254)

Ramat Gan, Israel

Sourasky Medical Center ( Site 1255)

Tel Aviv, Israel

AOU Cagliari ( Site 1306)

Monserrato, Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 1300)

Milan, Italy

Ospedale San Raffaele. ( Site 1305)

Milan, Italy

Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)

Naples, Italy

Istituto Oncologico Veneto IRCCS ( Site 1307)

Padova, Italy

Azienda USL della Romagna ( Site 1303)

Ravenna, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)

Verona, Italy

National Cancer Center Hospital East ( Site 0851)

Kashiwa, Japan

Teine Keijinkai Hospital ( Site 0864)

Sapporo, Japan

Kagawa University Hospital ( Site 0861)

Kita-gun, Japan

Kanagawa Cancer Center ( Site 0865)

Yokohama, Japan

Tohoku University Hospital ( Site 0853)

Sendai, Japan

Kindai University Hospital ( Site 0854)

Sakai, Japan

Saitama Medical University International Medical Center ( Site 0860)

Hidaka, Japan

Saitama Prefectural Cancer Center ( Site 0857)

Kitaadachi-gun, Japan

Shizuoka Cancer Center ( Site 0856)

Sunto-gun, Japan

Nippon Medical School Hospital ( Site 0859)

Bunkyo, Japan

National Cancer Center Hospital ( Site 0850)

Chūō, Japan

Cancer Institute Hospital of JFCR ( Site 0863)

Koto, Japan

Chiba Cancer Center ( Site 0858)

Chiba, Japan

Kyushu University Hospital ( Site 0862)

Fukuoka, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0852)

Osaka, Japan

Hospital Pulau Pinang ( Site 0550)

George Town, Malaysia

National Cancer Institute ( Site 0552)

Putrajaya, Malaysia

Sarawak General Hospital ( Site 0551)

Kuching, Malaysia

Centro de Inmuno Oncología de Occidente SA de CV ( Site 0403)

Guadalajara, Mexico

Higiea Oncologia ( Site 0404)

Mexico City, Mexico

Oncare Oncology (Servicios de Oncologia Médica Integral S.A. de C.V. - unidad San Pedro) ( Site 0407)

San Pedro Garza García, Mexico

Centro de Investigación Oncológica Galerías SC ( Site 0408)

Aguascalientes, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0402)

Oaxaca City, Mexico

Radboudumc ( Site 1354)

Nijmegen, Netherlands

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)

Breda, Netherlands

Amsterdam UMC, locatie VUmc ( Site 1351)

Amsterdam, Netherlands

Erasmus Medisch Centrum ( Site 1353)

Rotterdam, Netherlands

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)

Poznan, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1451)

Warsaw, Poland

Mrukmed ( Site 1450)

Rzeszów, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1452)

Gliwice, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1456)

Koszalin, Poland

Institutul Oncologic Cluj ( Site 1502)

Cluj-Napoca, Romania

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)

Cluj-Napoca, Romania

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)

Craiova, Romania

Fundeni Clinical Institute-Medical Oncology ( Site 1504)

Bucharest, Romania

Institutul Regional de Oncologie ( Site 1505)

Iași, Romania

National Cancer Centre Singapore ( Site 0650)

Singapore, Singapore

National Cancer Center ( Site 0702)

Goyang-si, South Korea

Seoul National University Bundang Hospital ( Site 0705)

Seongnam-si, South Korea

The Catholic University of Korea St. Vincent s Hospital ( Site 0703)

Suwon, South Korea

Samsung Medical Center ( Site 0708)

Gangnam, South Korea

Asan Medical Center ( Site 0707)

Songpa-gu, South Korea

Kyungpook National University Chilgok Hospital ( Site 0701)

Buk-Gu, South Korea

Seoul National University Hospital ( Site 0706)

Seoul, South Korea

Korea University Guro Hospital ( Site 0704)

Seoul, South Korea

Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)

Badalona, Spain

Hospital Universitario Marqués de Valdecilla ( Site 1551)

Santander, Spain

Hospital Insular de Gran Canaria ( Site 1558)

Las Palmas de Gran Canaria, Spain

Hospital Universitario Central de Asturias ( Site 1550)

Oviedo, Spain

Hospital Universitari Vall d'Hebron ( Site 1553)

Barcelona, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)

Madrid, Spain

Hospital Clinico San Carlos ( Site 1555)

Madrid, Spain

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)

Seville, Spain

Instituto Valenciano de Oncologia - IVO ( Site 1557)

Valencia, Spain

National Cheng Kung University Hospital ( Site 0754)

Tainan, Taiwan

National Taiwan University Hospital ( Site 0751)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 0752)

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)

Taoyuan, Taiwan

Hacettepe Universite Hastaneleri ( Site 1650)

Sıhhiye, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1652)

Adana, Turkey (Türkiye)

Gazi Universitesi ( Site 1651)

Ankara, Turkey (Türkiye)

Dicle Üniversitesi ( Site 1654)

Diyarbakır, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa ( Site 1656)

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 1653)

Izmir, Turkey (Türkiye)

MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)

Cherkasy, Ukraine

RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)

Chernivtsi, Ukraine

MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)

Ivano-Frankivsk, Ukraine

CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)

Kropyvnytskyi, Ukraine

MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)

Lviv, Ukraine

MNE "Central City Hospital" ( Site 1711)

Rivne, Ukraine

ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)

Lutsk, Ukraine

Uzhgorod Central City Clinical Hospital ( Site 1700)

Uzhhorod, Ukraine

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)

Kyiv, Ukraine

SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)

Kyiv, Ukraine

LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)

Kyiv, Ukraine

Heartlands Hospital ( Site 1759)

Birmingham, United Kingdom

University College London Hospitals ( Site 1750)

London, United Kingdom

Churchill Hospital ( Site 1756)

Oxford, United Kingdom

University Hospital Coventry & Warwickshire ( Site 1761)

Coventry, United Kingdom

Velindre Cancer Centre Hospital ( Site 1753)

Cardiff, United Kingdom

The Christie NHS Foundation Trust ( Site 1755)

Manchester, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.

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