Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
Completed · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses
Key facts
- Study ID
- NCT06242691
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 13
- Starts
- 2024-02-28
- Expected to finish
- 2025-06-17
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
- Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to < Grade 1 or baseline
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
- Received and progressed on or after 1 or 2 prior lines of therapy
You may not qualify if…
- Active severe digestive disease
- History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
- Diabetes or hypertension that cannot be controlled by medication
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active infection requiring systemic therapy
- Have not adequately recovered from major surgery or have ongoing surgical complications
Where it is running
- The University of Louisville, James Graham Brown Cancer Center ( Site 0004) — Louisville, Kentucky, United States
- START Midwest ( Site 0014) — Grand Rapids, Michigan, United States
- South Texas Accelerated Research Therapeutics (START) ( Site 0005) — San Antonio, Texas, United States
- START Mountain Region ( Site 0015) — West Valley City, Utah, United States
- University of Virginia Health System-Hematology-Oncology ( Site 0009) — Charlottesville, Virginia, United States
- The Alfred Hospital ( Site 0103) — Melbourne, Victoria, Australia
- Bradfordhill-Clinical Area ( Site 0301) — Santiago, Region M. de Santiago, Chile
- Beijing Cancer hospital-Digestive Oncology ( Site 0401) — Beijing, Beijing Municipality, China
- Fujian Cancer Hospital-oncology department ( Site 0409) — Fuzhou, Fujian, China
- First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415) — Huai'an, Jiangsu, China
- Rambam Health Care Campus-Oncology Division ( Site 0602) — Haifa, Israel
- Hadassah Medical Center ( Site 0604) — Jerusalem, Israel
- Rabin Medical Center-Oncology ( Site 0603) — Petah Tikva, Israel
- Sheba Medical Center ( Site 0605) — Ramat Gan, Israel
- Sourasky Medical Center ( Site 0601) — Tel Aviv, Israel
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1003) — Seoul, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.