Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
NCT ID: NCT06242691
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
304 participants
INTERVENTIONAL
2024-02-28
2025-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: MK-1200
In Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met.
MK-1200
IV Infusion
Antiemetic
One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion
Part 2: MK-1200 Cohort A
In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 via IV infusion Q2W until any discontinuation criteria are met.
MK-1200
IV Infusion
Antiemetic
One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion
Part 2: MK-1200 Cohort B
In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 via IV infusion Q2W until any discontinuation criteria are met.
MK-1200
IV Infusion
Antiemetic
One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion
Interventions
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MK-1200
IV Infusion
Antiemetic
One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Rambam Health Care Campus-Oncology Division ( Site 0602)
Haifa, , Israel
Hadassah Medical Center ( Site 0604)
Jerusalem, , Israel
Rabin Medical Center-Oncology ( Site 0603)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0605)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0601)
Tel Aviv, , Israel
Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
Seoul, , South Korea
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-508684-68-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1298-7820
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-1200-002
Identifier Type: OTHER
Identifier Source: secondary_id
1200-002
Identifier Type: -
Identifier Source: org_study_id
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