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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06242691




Registration number
NCT06242691
Ethics application status
Date submitted
26/01/2024
Date registered
5/02/2024

Titles & IDs
Public title
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
Scientific title
A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
2023-508684-68
Secondary ID [2] 0 0
1200-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MK-1200
Treatment: Drugs - Antiemetic

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Other: MK-1200
IV Infusion

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants who Experience One or More Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to approximately 28 days
Primary outcome [2] 0 0
Number of Participants who Experience One or More Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 34 months
Primary outcome [3] 0 0
Number of Participants who Discontinue Study Intervention Due to an AE
Timepoint [3] 0 0
Up to approximately 34 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 36 months
Secondary outcome [2] 0 0
ORR per RECIST 1.1 as Assessed by Investigator
Timepoint [2] 0 0
Up to approximately 36 months
Secondary outcome [3] 0 0
Area under the curve (AUC) of MK-1200
Timepoint [3] 0 0
Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to ~24 months): predose and 0.5 hours postdose. Cycle is 14 days.
Secondary outcome [4] 0 0
Minimum Concentration (Cmin) of MK-1200
Timepoint [4] 0 0
Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to ~24 months): predose and 0.5 hours postdose. Cycle is 14 days.
Secondary outcome [5] 0 0
Maximum Concentration (Cmax) of MK-1200
Timepoint [5] 0 0
Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to ~24 months): predose and 0.5 hours postdose. Cycle is 14 days.
Secondary outcome [6] 0 0
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Timepoint [6] 0 0
Up to approximately 36 months
Secondary outcome [7] 0 0
DOR per RECIST 1.1 as Assessed by Investigator
Timepoint [7] 0 0
Up to approximately 36 months
Secondary outcome [8] 0 0
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Timepoint [8] 0 0
Up to approximately 36 months
Secondary outcome [9] 0 0
PFS per RECIST 1.1 as Assessed by Investigator
Timepoint [9] 0 0
Up to approximately 36 months
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
Up to approximately 36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/01/2026
Actual
Sample size
Target
304
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital ( Site 0103) - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Chile
State/province [6] 0 0
Region M. De Santiago
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Fujian
Country [9] 0 0
China
State/province [9] 0 0
Jiangsu
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Israel
State/province [12] 0 0
Petah Tikva
Country [13] 0 0
Israel
State/province [13] 0 0
Ramat Gan
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06242691