A Phase I/II Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors

Study Identifier:
MK-1200-002
CT.gov Identifier:
NCT06242691
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508684-68-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1
    • Read More
  • Drug: Experimental: Part 2
  • Drug: iological: MK-1200
  • Drug: Drug: Antiemetic
  • Drug: Experimental drug
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    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
    • - 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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor