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Clinical Trials in the USA / NCT05067283
Recruiting Phase 1

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

NCT05067283 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1
Started
2021-12-17
Last updated
2026-09-14

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CalderasibPembrolizumabcarboplatinpemetrexedcetuximaboxaliplatinleucovorin5-fluorouracil

Calderasib: Oral dose

Pembrolizumab: Intravenous infusion of 200 mg

carboplatin: Per label

pemetrexed: Per label

cetuximab: Per label

oxaliplatin: Per label

leucovorin: Per label

5-fluorouracil: Per label

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (75)

FacilityCityRegionStatus
Moffitt Cancer Center ( Site 0261) Tampa Florida Recruiting
START Midwest ( Site 0267) Grand Rapids Michigan Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260) Hackensack New Jersey Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0270) New York New York Completed
NEXT Virginia ( Site 0271) Fairfax Virginia Recruiting
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262) Milwaukee Wisconsin Recruiting
Instituto Alexander Fleming ( Site 0434) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Sanatorio Parque ( Site 0456) Rosario Santa Fe Province Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438) La Rioja Argentina Recruiting
Chris O'Brien Lifehouse ( Site 0002) Camperdown New South Wales Recruiting
Liverpool Hospital-Medical Oncology ( Site 0001) Liverpool New South Wales Recruiting
Westmead Hospital ( Site 0006) Westmead New South Wales Recruiting
Monash Health-Oncology Research ( Site 0003) Clayton Victoria Recruiting
Cross Cancer Institute ( Site 0033) Edmonton Alberta Recruiting
The Moncton Hospital ( Site 0037) Moncton New Brunswick Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030) Hamilton Ontario Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036) Kingston Ontario Recruiting
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032) Toronto Ontario Recruiting
James Lind Centro de Investigacion del Cancer ( Site 0043) Temuco Araucania Completed
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041) Santiago Region M. de Santiago Recruiting
FALP-UIDO ( Site 0040) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0042) Santiago Region M. de Santiago Recruiting
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417) Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital ( Site 0419) Fuzhou Fujian Recruiting
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413) Guangzhou Guangdong Recruiting
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415) Guangzhou Guangdong Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418) Wuhan Hubei Recruiting
Jilin Cancer Hospital-oncology department ( Site 0412) Changchun Jilin Completed
Shanghai Chest Hospital-Oncology department ( Site 0410) Shanghai Shanghai Municipality Recruiting
Shanghai East Hospital ( Site 0416) Shanghai Shanghai Municipality Recruiting
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411) Hangzhou Zhejiang Recruiting
Odense Universitetshospital-Department of oncology ( Site 0421) Odense Region Syddanmark Recruiting
Rambam Health Care Campus-Oncology ( Site 0090) Haifa Israel Recruiting
Shaare Zedek Medical Center-Oncology ( Site 0092) Jerusalem Israel Recruiting
Hadassah Medical Center-Oncology ( Site 0094) Jerusalem Israel Recruiting
Meir Medical Center. ( Site 0091) Kfar Saba Israel Recruiting
Sheba Medical Center-ONCOLOGY ( Site 0093) Ramat Gan Israel Recruiting
Humanitas ( Site 0113) Rozzano Lombardy Recruiting
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111) Siena Tuscany Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110) Naples Italy Recruiting

+ 35 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05067283 on ClinicalTrials.gov ↗ ← All trials in the USA