Esophageal Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

304

Study ID:

NCT06242691

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 6 Locations for this study

See Locations Near You

South Texas Accelerated Research Therapeutics (START) ( Site 0005)
San Antonio Texas, 78229, United States More Info
Study Coordinator
Contact
210-593-5250
The Alfred Hospital ( Site 0103)
Melbourne Victoria, 3004, Australia More Info
Study Coordinator
Contact
61390763129
Rambam Health Care Campus-Oncology Division ( Site 0602)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247776700
Hadassah Medical Center ( Site 0604)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226777957
Sheba Medical Center ( Site 0605)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
97235304448
Sourasky Medical Center ( Site 0601)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
97236973082

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

304

Study ID:

NCT06242691

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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