The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.
Time frame: Up to approximately 56 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 56 months
Area Under the Concentration Time-curve From Time 0 to the End of the Dosing Period (AUCtau) of MK-0472
Blood samples will be collected at specified intervals for the determination of AUCtau. AUCtau is defined as the area under concentration-time curve from 0 to the end of the dosing period.
Time frame: At predetermined timepoints predose and postdose up to Cycle 6 (Each cycle length = 21 Days)
Lowest Plasma Concentration (Ctrough) of MK-0472
Blood samples will be collected at specified intervals for the determination of Ctrough. Ctrough is defined as the lowest concentration of MK-0472 reached before the next dose is administered.
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Northwestern Memorial Hospital ( Site 0002)
Chicago, Illinois, United States
RECRUITINGThe University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, United States
RECRUITINGJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Hackensack, New Jersey, United States
RECRUITINGRutgers Cancer Institute of New Jersey ( Site 0005)
New Brunswick, New Jersey, United States
RECRUITINGPrincess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Montreal, Quebec, Canada
RECRUITINGJewish General Hospital ( Site 0104)
Montreal, Quebec, Canada
RECRUITINGCentro de Estudios Clínicos SAGA ( Site 0701)
Santiago, Region M. de Santiago, Chile
RECRUITINGFundacion Arturo Lopez Perez ( Site 0700)
Santiago, Region M. de Santiago, Chile
RECRUITINGCentro de Investigacion Clinicadela Universidad Catolica ( Site 0703)
Santiago, Region M. de Santiago, Chile
RECRUITING...and 15 more locations
Time frame: At predetermined timepoints Predose up to Cycle 6 (Each cycle length = 21 Days)
Maximum Plasma Concentration (Cmax) of MK-0472
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-0472 reached.
Time frame: At predetermined timepoints postdose up to Cycle 6 (Each cycle length = 21 Days)