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)
Merck Sharp & Dohme LLC
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCalderasib
Oral administration
- BiologicalCetuximab
Intravenous administration
Locations (50)
- Greater Baltimore Medical Center ( Site 1104)Baltimore, Maryland
- START Midwest ( Site 1103)Grand Rapids, Michigan
- Comprehensive Cancer Centers of Nevada ( Site 1109)Las Vegas, Nevada
- Rutgers Cancer Institute of New Jersey ( Site 1100)New Brunswick, New Jersey
- START Mountain Region ( Site 1106)West Valley City, Utah
- Virginia Cancer Specialists ( Site 1102)Fairfax, Virginia