MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Northwestern University ( Site 0101)
Chicago, Illinois, United States
RECRUITINGJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)
Hackensack, New Jersey, United States
RECRUITINGHouston Methodist Hospital ( Site 0103)
Number of participants who experience one or more dose-limiting toxicities (DLTs)
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.
Time frame: Up to approximately 35 days
Number of Participants Who Experience an Adverse Event (AE)
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.
Time frame: Up to approximately 2 years
Number of Participants Who Discontinue Study Intervention Due to an AE
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/study treatment due to an AE will be reported.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294
Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Area Under the Concentration-Time Curve of MK-8294.
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1 mg via intravenous (IV) infusion
3 mg via intravenous (IV) infusion
10 mg via intravenous (IV) infusion
30 mg via intravenous (IV) infusion
70 mg via intravenous (IV) infusion
IV Infusion
Houston, Texas, United States
Rambam Health Care Campus ( Site 0201)
Haifa, Israel
RECRUITINGSheba Medical Center ( Site 0200)
Ramat Gan, Israel
RECRUITINGRadboudumc ( Site 0301)
Nijmegen, Gelderland, Netherlands
RECRUITINGNederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)
Amsterdam, North Holland, Netherlands
RECRUITINGTime frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Minimum Concentration (Cmin) of MK-8294
Cmin is defined as the lowest concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmin of MK-8294.
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Maximum Plasma Concentration (Cmax) of MK-8294
Cmax is defined as the peak concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmax of MK-8294.
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-8294
Tmax is defined as the time to reach Cmax. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Tmax of MK-8294.
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Incidence of Antidrug Antibodies (ADA) to MK-8294
Blood samples will be collected pre-dose and at designated time points to determine the ADA response to MK-8294. The incidence of ADAs over time will be presented.
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Titer of ADA to MK-8294
Blood samples will be collected pre-dose and at designated time points to determine the ADA titers to MK-8294.
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)