A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors
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.
Arms & interventions
- DrugMK-8294
30 µg via intravenous (IV) infusion
- DrugMK-8294
100 µg via intravenous (IV) infusion
- DrugMK-8294
300 µg via intravenous (IV) infusion
- DrugMK-8294
1 mg via intravenous (IV) infusion
- DrugMK-8294
3 mg via intravenous (IV) infusion
- DrugMK-8294
10 mg via intravenous (IV) infusion
- DrugMK-8294
30 mg via intravenous (IV) infusion
- DrugMK-8294
70 mg via intravenous (IV) infusion
- OtherCD8 PET Tracer
IV Infusion
Outcome measures
Primary
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
Secondary
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) 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
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
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
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
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
Time frame: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)
Eligibility criteria
Study locations (1)
Northwestern University ( Site 0101)
Chicago, Illinois, 60611