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NCT05067283

PHASE1

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

Official title: A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

830

Start Date

2021-12-17

Completion Date

2030-02-25

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Advanced Solid Tumors

Interventions

DRUG

Calderasib

Oral dose

BIOLOGICAL

Pembrolizumab

Intravenous infusion of 200 mg

DRUG

carboplatin

Per label

DRUG

pemetrexed

Per label

BIOLOGICAL

cetuximab

Per label

DRUG

oxaliplatin

Per label

DRUG

leucovorin

Per label

DRUG

5-fluorouracil

Per label

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 histologically 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 * 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

Locations (73)

Moffitt Cancer Center ( Site 0261)

Tampa, Florida, United States

START Midwest ( Site 0267)

Grand Rapids, Michigan, United States

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

Hackensack, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center ( Site 0270)

New York, New York, United States

NEXT Virginia ( Site 0271)

Fairfax, Virginia, United States

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

Milwaukee, Wisconsin, United States

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

La Rioja, Argentina

Chris O'Brien Lifehouse ( Site 0002)

Camperdown, New South Wales, Australia

Liverpool Hospital-Medical Oncology ( Site 0001)

Liverpool, New South Wales, Australia

Westmead Hospital ( Site 0006)

Westmead, New South Wales, Australia

Monash Health-Oncology Research ( Site 0003)

Clayton, Victoria, Australia

Cross Cancer Institute ( Site 0033)

Edmonton, Alberta, Canada

The Moncton Hospital ( Site 0037)

Moncton, New Brunswick, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)

Hamilton, Ontario, Canada

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

Kingston, Ontario, Canada

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

Toronto, Ontario, Canada

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)

Santiago, Region M. de Santiago, Chile

FALP-UIDO ( Site 0040)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0042)

Santiago, Region M. de Santiago, Chile

James Lind Centro de Investigacion del Cancer ( Site 0043)

Temuco, Región de la Araucanía, Chile

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

Beijing, Beijing Municipality, China

Fujian Cancer Hospital ( Site 0419)

Fuzhou, Fujian, China

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

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

Jilin Cancer Hospital-oncology department ( Site 0412)

Changchun, Jilin, China

Shanghai Chest Hospital-Oncology department ( Site 0410)

Shanghai, Shanghai Municipality, China

Shanghai East Hospital ( Site 0416)

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)

Hangzhou, Zhejiang, China

Odense Universitetshospital-Department of oncology ( Site 0421)

Odense, Region Syddanmark, Denmark

Rambam Health Care Campus-Oncology ( Site 0090)

Haifa, Israel

Shaare Zedek Medical Center-Oncology ( Site 0092)

Jerusalem, Israel

Hadassah Medical Center-Oncology ( Site 0094)

Jerusalem, Israel

Meir Medical Center. ( Site 0091)

Kfar Saba, Israel

Sheba Medical Center-ONCOLOGY ( Site 0093)

Ramat Gan, Israel

Humanitas ( Site 0113)

Rozzano, Lombardy, Italy

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

Siena, Tuscany, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)

Naples, Italy

National Cancer Center Hospital East ( Site 0404)

Kashiwa, Chiba, Japan

Kanagawa Cancer Center ( Site 0402)

Yokohama, Kanagawa, Japan

Shizuoka Cancer Center ( Site 0401)

Nakatogari, Shizuoka, Japan

National Cancer Center Hospital ( Site 0403)

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 0400)

Koto, Tokyo, Japan

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

Kaunas, Kaunas County, Lithuania

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

Vilnius, Lithuania

Sarawak General Hospital ( Site 0453)

Kuching, Sarawak, Malaysia

New Zealand Clinical Research (Christchurch) ( Site 0004)

Christchurch, Canterbury, New Zealand

Centro Oncologico de Panama ( Site 0160)

Panama City, Panama

Centro Hemato Oncológico Paitilla ( Site 0163)

Panama City, Panama

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)

Poznan, Greater Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)

Koszalin, West Pomeranian Voivodeship, Poland

Seoul National University Hospital ( Site 0191)

Seoul, South Korea

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

Seoul, South Korea

Clinica Universidad de Navarra ( Site 0213)

Madrid, Madrid, Comunidad de, Spain

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

Madrid, Madrid, Comunidad de, Spain

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

Barcelona, Spain

Cantonal Hospital St.Gallen ( Site 0224)

Sankt Gallen, Canton of St. Gallen, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 0220)

Bellinzona, Canton Ticino, Switzerland

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

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

National Cheng Kung University Hospital ( Site 0444)

Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 0443)

Taipei, Taiwan

Ege University Medicine of Faculty ( Site 0231)

Bornova, İzmir, Turkey (Türkiye)

Erciyes University ( Site 0232)

Talas, Kayseri, Turkey (Türkiye)

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)

Ankara, Turkey (Türkiye)

Ankara City Hospital-oncology ( Site 0233)

Ankara, Turkey (Türkiye)

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

Cherkasy, Cherkasy Oblast, Ukraine

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Rivne Regional Clinical Hospital ( Site 0257)

Rivne, Rivne Oblast, Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)

Rivne, Rivne Oblast, Ukraine

Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)

Uzhhorod, Zakarpattia Oblast, Ukraine

Clinical Research Directory

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)