Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (>4 weeks) antiretroviral therapy (ART)
Disqualifiers
Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study
Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
History of hyperparathyroidism or hypercalcemia
Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease
Trial design
Design model
Parallel
Treatments tested in this trial
MK-0472
DrugOral Administration
Pembrolizumab
Biological/VaccineIV infusion
MK-1084
DrugOral Administration
Treatment groups
178 Participants
are divided into 3 treatment groupsGroup A: MK-0472Experimental treatment 1 intervention
Group B: MK-0472 + PembrolizumabExperimental treatment 2 interventions
Group C: MK-0472 + MK-1084Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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 months3
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 monthsSecondary outcomes
1
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)2
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.
Time frame
At predetermined timepoints Predose up to Cycle 6 (Each cycle length = 21 Days)3
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)Sponsors and contacts
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Source ClinicalTrials.gov