A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Recruiting now · Phase 2
Conditions studied: Neoplasm Malignant
In brief
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.
Key facts
- Study ID
- NCT07209111
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 150
- Starts
- 2025-12-04
- Expected to finish
- 2032-04-09
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- START Midwest ( Site 1103) — Grand Rapids, Michigan, United States (enrolling)
- Comprehensive Cancer Centers of Nevada ( Site 1109) — Las Vegas, Nevada, United States (enrolling)
- Rutgers Cancer Institute of New Jersey ( Site 1100) — New Brunswick, New Jersey, United States (enrolling)
- START Mountain Region ( Site 1106) — West Valley City, Utah, United States (enrolling)
- Virginia Cancer Specialists ( Site 1102) — Fairfax, Virginia, United States (enrolling)
- Prince of Wales Hospital-Medical Oncology ( Site 1003) — Randwick, New South Wales, Australia (enrolling)
- Westmead Hospital ( Site 1000) — Westmead, New South Wales, Australia (enrolling)
- Epworth Freemasons ( Site 1004) — Melbourne, Victoria, Australia (enrolling)
- The Ottawa Hospital ( Site 2902) — Ottawa, Ontario, Canada (enrolling)
- Jewish General Hospital-CRU ( Site 2900) — Montreal, Quebec, Canada (enrolling)
- FALP ( Site 1200) — Santiago, Region M. de Santiago, Chile (enrolling)
- Centro de Oncología de Precisión ( Site 1202) — Santiago, Region M. de Santiago, Chile (enrolling)
- Clinica San Carlos de Apoquindo ( Site 1203) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 1201) — Santiago, Region M. de Santiago, Chile (enrolling)
- Beijing Cancer hospital ( Site 1318) — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital of Xiamen University ( Site 1304) — Xiamen, Fujian, China (enrolling)
- Sun Yat-sen University Cancer Center ( Site 1303) — Guangzhou, Guangdong, China (enrolling)
- The first affiliated hospital, Sun Yat-Sen university ( Site 1329) — Guangzhou, Guangdong, China (enrolling)
- Harbin Medical University Cancer Hospital ( Site 1308) — Harbin, Heilongjiang, China (enrolling)
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326) — Wuhan, Hubei, China (enrolling)
- Hunan Cancer Hospital ( Site 1321) — Changsha, Hunan, China (enrolling)
- Jiangsu Province Hospital ( Site 1324) — Nanjing, Jiangsu, China (enrolling)
- The First Affiliated Hospital of Nanchang University ( Site 1307) — Nanchang, Jiangxi, China (enrolling)
- Jinan Central Hospital ( Site 1313) — Jinan, Shandong, China (enrolling)
- Greater Baltimore Medical Center ( Site 1104) — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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