Who is eligible for clinical trial NCT05853367?

Participants must meet protocol criteria for Metastatic Solid Tumors. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05853367 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-04

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001) (NCT05853367)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (21 items).

Location: Northwestern Memorial Hospital ( Site 0002) — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria: 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
Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing
Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event
Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (25 Sites)

Northwestern Memorial Hospital ( Site 0002) — Chicago, Illinois
The University of Louisville, James Graham Brown Cancer Center ( Site 0004) — Louisville, Kentucky
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) — Hackensack, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0005) — New Brunswick, New Jersey
Princess Margaret Cancer Centre ( Site 0101) — Toronto, Ontario
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100) — Montreal, Quebec
Département clinique de médecine de laboratoire du CHUM ( Site 0104) — Montreal, Quebec
Centro de Estudios Clínicos SAGA ( Site 0701) — Santiago, Region M. de Santiago
Fundacion Arturo Lopez Perez ( Site 0700) — Santiago, Region M. de Santiago
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703) — Santiago, Region M. de Santiago
Bradfordhill ( Site 0702) — Santiago, Region M. de Santiago
Rambam Health Care Campus ( Site 0304) — Haifa,
Shaare Zedek Medical Center ( Site 0303) — Jerusalem,
Rabin Medical Center ( Site 0301) — Petah Tikva,
Sheba Medical Center ( Site 0300) — Ramat Gan,
Sourasky Medical Center ( Site 0302) — Tel Aviv,
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401) — Warsaw, Masovian Voivodeship
Uniwersyteckie Centrum Kliniczne ( Site 0400) — Gdansk, Pomeranian Voivodeship
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501) — L'Hospitalet de Llobregat, Catalonia
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504) — Madrid, Madrid, Comunidad de
Hospital Universitari Vall d'Hebron ( Site 0500) — Barcelona,
Hospital Virgen del Rocio ( Site 0503) — Seville,
Hôpitaux Universitaires de Genève (HUG) ( Site 0202) — Geneva, Canton of Geneva
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201) — Sankt Gallen, Canton of St. Gallen
Ospedale Regionale Bellinzona e Valli ( Site 0200) — Bellinzona, Canton Ticino

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗