A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014
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 comp
| Condition(s) | Neoplasm Malignant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 p |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Locations | Baltimore, Maryland, United States; Grand Rapids, Michigan, United States; Las Vegas, Nevada, United States; New Brunswick, New Jersey, United States; West Valley City, Utah, United States; Fairfax, Virginia, United States (+54 more sites) |
| Start date | 2025-12-04 |
| NCT ID | NCT07209111 |
| Official listing | https://clinicaltrials.gov/study/NCT07209111 |