A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.
Summary
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.
Arms & interventions
- DrugMK-0472
Oral Administration
- BiologicalPembrolizumab
IV infusion
- DrugMK-1084
Oral Administration
Outcome measures
Primary
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
Secondary
Area Under the Concentration Time-curve From Time 0 to the End of the Dosing Period (AUCtau) of MK-0472
Time frame: At predetermined timepoints predose and postdose up to Cycle 6 (Each cycle length = 21 Days)
Lowest Plasma Concentration (Ctrough) of MK-0472
Time frame: At predetermined timepoints Predose up to Cycle 6 (Each cycle length = 21 Days)
Maximum Plasma Concentration (Cmax) of MK-0472
Time frame: At predetermined timepoints postdose up to Cycle 6 (Each cycle length = 21 Days)
Eligibility criteria
Study locations (4)
Northwestern Memorial Hospital ( Site 0002)
Chicago, Illinois, 60611
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, 40202
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Hackensack, New Jersey, 07601
Rutgers Cancer Institute of New Jersey ( Site 0005)
New Brunswick, New Jersey, 08901