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

Running, not enrolling · Phase 1

Conditions studied: Metastatic Solid Tumors, Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT05853367

Run by

Merck Sharp & Dohme LLC

People needed

95

Starts

2023-07-06

Expected to finish

2028-06-24

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
• Has known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
• Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has active infection requiring systemic therapy
• Has history of allogeneic tissue/solid organ transplant
• Have not adequately recovered from major surgery or have ongoing surgical complications

Where it is running

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

Full record on ClinicalTrials.gov

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