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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
25/06/2024
Titles & IDs
Public title
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
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Secondary ID [1]
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2023-508684-68
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Secondary ID [2]
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1200-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants who Experience One or More Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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The occurrence of any of the following toxicities within 28 days after the first dose of study intervention will be considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration:
* Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE =Grade 3 in severity should be considered a DLT, with pre-specified exceptions
* Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions
* Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol
* Prolonged delay (\>2 weeks) in initiating Cycle 2 due to intervention-related toxicity
* Any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1
* Missing \>25% of MK-1200 doses as a result of drug-related AEs during the first cycle
* Grade 5 toxicity
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Timepoint [1]
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Up to approximately 28 days
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Primary outcome [2]
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Number of Participants who Experience One or More Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported for each arm.
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Timepoint [2]
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Up to approximately 34 months
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Primary outcome [3]
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Number of Participants who Discontinue Study Intervention Due to an AE
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study intervention due to an AE will be reported for each arm.
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Timepoint [3]
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Up to approximately 34 months
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Secondary outcome [1]
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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)
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Assessment method [1]
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ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR).
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Timepoint [1]
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Up to approximately 36 months
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Secondary outcome [2]
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ORR per RECIST 1.1 as Assessed by Investigator
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Assessment method [2]
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ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator.
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Timepoint [2]
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Up to approximately 36 months
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Secondary outcome [3]
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Area under the curve (AUC) of MK-1200
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Assessment method [3]
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AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Minimum Concentration (Cmin) of MK-1200
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Assessment method [4]
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Cmin is defined as the minimum concentration of MK-1200 observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples will be collected at pre-specified timepoints to determine Cmin.
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Timepoint [4]
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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.
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Secondary outcome [5]
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Maximum Concentration (Cmax) of MK-1200
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Assessment method [5]
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Cmax is defined as the maximum or 'peak' concentration of MK-1200 observed after its administration. Blood samples will be collected at pre-specified timepoints to determine Cmax.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
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Assessment method [6]
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For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR will be reported.
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Timepoint [6]
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Up to approximately 36 months
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Secondary outcome [7]
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DOR per RECIST 1.1 as Assessed by Investigator
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Assessment method [7]
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For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator will be reported.
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Timepoint [7]
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Up to approximately 36 months
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Secondary outcome [8]
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Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
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Assessment method [8]
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PFS is defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be reported.
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Timepoint [8]
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Up to approximately 36 months
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Secondary outcome [9]
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PFS per RECIST 1.1 as Assessed by Investigator
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Assessment method [9]
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PFS is defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be reported.
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Timepoint [9]
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Up to approximately 36 months
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Secondary outcome [10]
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Overall Survival (OS)
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Assessment method [10]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [10]
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Up to approximately 36 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/01/2026
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Actual
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Sample size
Target
304
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital ( Site 0103) - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Michigan
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Chile
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State/province [3]
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Region M. De Santiago
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Country [4]
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Israel
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State/province [4]
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Haifa
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Country [5]
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Israel
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State/province [5]
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Jerusalem
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Country [6]
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Israel
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State/province [6]
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Petah Tikva
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Country [7]
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Israel
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State/province [7]
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Ramat Gan
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Country [8]
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Israel
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State/province [8]
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Tel Aviv
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT06242691
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06242691
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