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
Qualifiers
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
Treatments tested in this trial
- MK-0472
- Pembrolizumab
- MK-1084
Treatment groups
178 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov