RecruitingMetastatic Solid TumorsAdvanced Solid Tumors
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Merck Sharp & Dohme LLC
You may qualify if…
- ✓ The main inclusion criteria include but are not limited to the following:
- ✓ 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)
- ✓ Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit
- ✓ Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)/ligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma
- ✓ Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation
You may not qualify if…
- ✕ The main exclusion criteria include but are not limited to the following:
- ✕ 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
- ✕ Has clinically significant cardiovascular disease
- ✕ Bullous exfoliative skin disorders of any grade
- ✕ Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients
Where it's recruiting
Source: ClinicalTrials.gov · NCT05853367 · last updated 2026-06-15