Metastatic Neoplasm
Conditions
Keywords
Metastases, Neoplasm
Brief summary
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.
Interventions
DRUGMK-8294
30 µg via intravenous (IV) infusion
OTHERCD8 PET Tracer
IV Infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor \[ER\]/progesterone receptor +, human epidermal growth factor receptor 2 negative \[HER2-\]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive 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 history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more dose-limiting toxicities (DLTs) | Up to approximately 35 days | 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. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 2 years | 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 2 years | 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. |
| Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | 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. |
| Minimum Concentration (Cmin) of MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | 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. |
| Maximum Plasma Concentration (Cmax) of MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | 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 to Maximum Plasma Concentration (Tmax) of MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | 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. |
| Incidence of Antidrug Antibodies (ADA) to MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | 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. |
| Titer of ADA to MK-8294 | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) | Blood samples will be collected pre-dose and at designated time points to determine the ADA titers to MK-8294. |
Countries
Israel, Netherlands, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed