A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07209111
This study evaluates calderasib, alone or with cetuximab, in treating advanced solid tumors with KRAS G12C mutation. Eligible participants have progressed on standard treatments and have non-colorectal tumors. Calderasib is administered orally, while cetuximab is given intravenously. The trial assesses tumor response and treatment safety.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Greater Baltimore Medical Center ( Site 1104) | 21204 | Baltimore | Maryland |
| START Midwest ( Site 1103) | 49546 | Grand Rapids | Michigan |
| Comprehensive Cancer Centers of Nevada ( Site 1109) | 89169 | Las Vegas | Nevada |
| Rutgers Cancer Institute of New Jersey ( Site 1100) | 08903 | New Brunswick | New Jersey |
| START Mountain Region ( Site 1106) | 84119 | West Valley City | Utah |
| Virginia Cancer Specialists ( Site 1102) | 22031 | Fairfax | Virginia |
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