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RECRUITINGPHASE1

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

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

NCT05067283•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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
+3 more criteria

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

Key Dates

Start Date

December 17, 2021

Primary Completion Date

February 25, 2030

Completion Date

February 25, 2030

Last Updated

February 12, 2026

Enrollment

830

ESTIMATED participants

Conditions

Advanced Solid Tumors

Interventions

Calderasib

DRUG

Pembrolizumab

BIOLOGICAL

carboplatin

DRUG

pemetrexed

DRUG

cetuximab

BIOLOGICAL

oxaliplatin

DRUG

leucovorin

DRUG

5-fluorouracil

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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A Study of ASP1002 in Adults for Treatment of Solid Tumors

NCT05719558

Advanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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