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Safety and Efficacy of MK-1200 in Participants with Advanced Solid Tumors

ClinicalTrials.gov Identifier: NCT06242691 (view full study on clinicaltrials.gov)
Condition:  Advanced Solid Tumors
Status:  Recruiting


Official Title: A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants with Advanced Solid Tumors

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

Interventional
Phase 1/Phase 2
304
February 2024
January 2026
January 2026
18 years and older
All
No


CRITERIA

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active severe digestive disease
  • History of major cardiovascular diseases
  • History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
  • Cardiac pacemaker use
  • 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

United States     Toll Free Number     1-800-770-4674   

  • San Antonio, Texas, 78229

No Study Results Posted



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