Status:
RECRUITING
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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
Key Trial Info
Start Date :
December 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 9 2032
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07209111
Start Date
December 4 2025
End Date
April 9 2032
Last Update
April 13 2026
Active Locations (44)
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1
Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, United States, 21204
2
START Midwest ( Site 1103)
Grand Rapids, Michigan, United States, 49546
3
Comprehensive Cancer Centers of Nevada ( Site 1109)
Las Vegas, Nevada, United States, 89169
4
Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey, United States, 08903