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

RECRUITINGPhase 2Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 2
SponsorMerck Sharp & Dohme LLC
Started2025-12-04
Est. completion2032-04-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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 Years+Healthy volunteers accepted
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* 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:

The main exclusion criteria include but are not limited to the following:

* 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

Conditions2

CancerNeoplasm Malignant

Locations4 sites

Maryland

1 site
Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, 21204
Study Coordinator443-849-3285

Michigan

1 site
START Midwest ( Site 1103)
Grand Rapids, Michigan, 49546
Study Coordinator616-389-1808

Utah

1 site
START Mountain Region ( Site 1106)
West Valley City, Utah, 84119
Study Coordinator210-593-5250

Virginia

1 site
Virginia Cancer Specialists ( Site 1102)
Fairfax, Virginia, 22031
Study Coordinator703-208-9268

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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