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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
Locations6 sites
View on ClinicalTrials.gov →
NCT07209111
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
Interventions2
Locations6 sites
Greater Baltimore Medical Center ( Site 1104)
Study Coordinator443-849-3285
START Midwest ( Site 1103)
Grand Rapids, Michigan, 49546
Study Coordinator616-389-1808
Comprehensive Cancer Centers of Nevada ( Site 1109)
Study Coordinator702-952-3400
Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey, 08903
Study Coordinator732-235-3443
START Mountain Region ( Site 1106)
West Valley City, Utah, 84119
Study Coordinator210-593-5250
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Related trials
- MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) — Merck Sharp & Dohme LLC
- A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) — Merck Sharp & Dohme LLC
- A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) — Merck Sharp & Dohme LLC
- A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) — Merck Sharp & Dohme LLC
- A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) — Merck Sharp & Dohme LLC
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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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Actively Recruiting
PhasePhase 2
SponsorMerck Sharp & Dohme LLC
Started2025-12-04
Est. completion2032-04-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT07209111