Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)

Last updated: April 7, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

MK-1200

Antiemetic

Clinical Study ID

NCT06242691
1200-002
2023-508684-68
U1111-1298-7820
MK-1200-002
  • Ages > 18
  • All Genders

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. 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tractcancer, or pancreatic ductal adenocarcinoma

  • Participants who experienced Adverse Events (AEs) due to previous anticancertherapies must have recovered to < Grade 1 or baseline

  • Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on antiretroviral therapy

  • Hepatitis B surface antigen (HBsAg) positive participants are eligible if they havereceived Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and haveundetectable HBV viral load

  • Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCVviral load is undetectable

  • Received and progressed on or after 1 or 2 prior lines of therapy

Exclusion

Exclusion Criteria:

  • Active severe digestive disease

  • History of acute myocardial infarction; unstable angina; stroke or transientischemic 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 MulticentricCastleman's Disease

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before study intervention

  • Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids

  • Known additional malignancy that is progressing or has required active treatmentwithin 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 surgicalcomplications

Study Design

Total Participants: 304
Treatment Group(s): 2
Primary Treatment: MK-1200
Phase: 1/2
Study Start date:
February 28, 2024
Estimated Completion Date:
June 18, 2025

Connect with a study center

  • The Alfred Hospital ( Site 0103)

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Bradfordhill-Clinical Area ( Site 0301)

    Santiago, Region M. De Santiago 8420383
    Chile

    Site Not Available

  • Beijing Cancer hospital-Digestive Oncology ( Site 0401)

    Beijing, Beijing 100142
    China

    Site Not Available

  • Fujian Cancer Hospital-oncology department ( Site 0409)

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)

    Huai'an, Jiangsu 223300
    China

    Site Not Available

  • Rambam Health Care Campus-Oncology Division ( Site 0602)

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0604)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Rabin Medical Center-Oncology ( Site 0603)

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center ( Site 0605)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 0601)

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • The University of Louisville, James Graham Brown Cancer Center ( Site 0004)

    Louisville, Kentucky 40245
    United States

    Site Not Available

  • START Midwest ( Site 0014)

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics (START) ( Site 0005)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • START Mountain Region ( Site 0015)

    West Valley City, Utah 84119
    United States

    Site Not Available

  • University of Virginia Health System-Hematology-Oncology ( Site 0009)

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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