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A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

NCT07209111•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: * How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
•Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria

•Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
•Has known additional malignancy that is progressing or has required active treatment within the past 3 years
•Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
•Has active infection, other than those permitted per protocol, requiring systemic therapy
•Has not adequately recovered from major surgery or has ongoing surgical complications

Locations (40)

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, United States

START Midwest ( Site 1103)

Grand Rapids, Michigan, United States

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey, United States

START Mountain Region ( Site 1106)

West Valley City, Utah, United States

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia, United States

Prince of Wales Hospital-Medical Oncology ( Site 1003)

Randwick, New South Wales, Australia

Beijing Cancer hospital ( Site 1318)

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University ( Site 1304)

Xiamen, Fujian, China

Sun Yat-sen University Cancer Center ( Site 1303)

Guangzhou, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)

Wuhan, Hubei, China

Key Dates

Start Date

December 4, 2025

Primary Completion Date

April 9, 2032

Completion Date

April 9, 2032

Last Updated

March 20, 2026

Enrollment

150

ESTIMATED participants

Conditions

Neoplasm Malignant

Interventions

Calderasib

DRUG

Cetuximab

BIOLOGICAL

Contacts

Toll Free Number

CONTACT

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

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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: March 20, 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.

View ClinicalTrials.gov Terms and Conditions

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Inclusion Criteria

Exclusion Criteria

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