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Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT06242691•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•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

Locations (16)

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

Key Dates

Start Date

February 28, 2024

Primary Completion Date

June 17, 2025

Completion Date

June 17, 2025

Last Updated

March 6, 2026

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumors

Interventions

MK-1200

BIOLOGICAL

Antiemetic

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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