Trial Title:
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
NCT ID:
NCT06242691
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Antiemetics
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
MK-1200
Description:
IV Infusion
Arm group label:
Part 1: MK-1200
Arm group label:
Part 2: MK-1200 Cohort A
Arm group label:
Part 2: MK-1200 Cohort B
Intervention type:
Drug
Intervention name:
Antiemetic
Description:
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
Arm group label:
Part 1: MK-1200
Arm group label:
Part 2: MK-1200 Cohort A
Arm group label:
Part 2: MK-1200 Cohort B
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
Criteria for 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Address:
City:
Louisville
Zip:
40245
Country:
United States
Facility:
Name:
START Midwest ( Site 0014)
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Facility:
Name:
South Texas Accelerated Research Therapeutics (START) ( Site 0005)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
START Mountain Region ( Site 0015)
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Facility:
Name:
University of Virginia Health System-Hematology-Oncology ( Site 0009)
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Facility:
Name:
The Alfred Hospital ( Site 0103)
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0301)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Facility:
Name:
Beijing Cancer hospital-Digestive Oncology ( Site 0401)
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Fujian Cancer Hospital-oncology department ( Site 0409)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
Address:
City:
Huai'an
Zip:
223300
Country:
China
Facility:
Name:
Rambam Health Care Campus-Oncology Division ( Site 0602)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Facility:
Name:
Hadassah Medical Center ( Site 0604)
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Facility:
Name:
Rabin Medical Center-Oncology ( Site 0603)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Facility:
Name:
Sheba Medical Center ( Site 0605)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Facility:
Name:
Sourasky Medical Center ( Site 0601)
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Facility:
Name:
Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Start date:
February 28, 2024
Completion date:
January 3, 2026
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242691
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1200-002&kw=MK-1200-002
