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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516870-31-00 | Registry Identifier | EU CT | |
| U1111-1311-2807 | Registry Identifier | UTN | |
| MK-8294-001 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8294 | Experimental | Participants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8294 | Drug | 30 µg via intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University ( Site 0101) | Recruiting | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| MK-8294 | Drug | 100 µg via intravenous (IV) infusion |
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| MK-8294 | Drug | 300 µg via intravenous (IV) infusion |
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| MK-8294 | Drug | 1 mg via intravenous (IV) infusion |
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| MK-8294 | Drug | 3 mg via intravenous (IV) infusion |
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| MK-8294 | Drug | 10 mg via intravenous (IV) infusion |
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| MK-8294 | Drug | 30 mg via intravenous (IV) infusion |
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| MK-8294 | Drug | 70 mg via intravenous (IV) infusion |
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| CD8 PET Tracer | Other | IV Infusion |
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| 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. | 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. | 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. | 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. | 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. | 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. | Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks) |
| Rambam Health Care Campus ( Site 0201) | Recruiting | Haifa | 3109601 | Israel |
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| Sheba Medical Center ( Site 0200) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Radboudumc ( Site 0301) | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300) | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
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