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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
Date last updated
28/08/2024

Titles & IDs
Public title
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
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
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
Trial website
https://clinicaltrials.gov/study/NCT06242691
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06242691