A Phase 1 interventional study of MK-8294 and MK-8294 in Metastatic Neoplasm, sponsored by Merck Sharp & Dohme LLC. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 67 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Drug: MK-8294 · Other: CD8 PET Tracer
30 µg via intravenous (IV) infusion
Also known as: DAB014236
100 µg via intravenous (IV) infusion
Also known as: DAB014236
300 µg via intravenous (IV) infusion
Also known as: DAB014236
1 mg via intravenous (IV) infusion
Also known as: DAB014236
3 mg via intravenous (IV) infusion
Also known as: DAB014236
10 mg via intravenous (IV) infusion
Also known as: DAB014236
30 mg via intravenous (IV) infusion
Also known as: DAB014236
70 mg via intravenous (IV) infusion
Also known as: DAB014236
IV Infusion
Also known as: GEH200520 + GEH200521 (18F)
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.
Time 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)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Merck Sharp & Dohme LLC