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NCT05853367

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~95 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:MK-0472PembrolizumabMK-1084

At a glance

Recruiting sites
0 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured over At the end of Cycle 1 (each cycle is 21 days)
+2 more outcomes measured

Conditions

Metastatic Solid Tumors
Advanced Solid Tumors

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Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Bradfordhill ( Site 0702)

    Santiago, Region M. de Santiago, Chileno site contact published

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201)

    Sankt Gallen, Canton of St. Gallen, Switzerlandno site contact published

  • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)

    Montreal, Quebec, Canadano site contact published

  • Centro de Estudios Clínicos SAGA ( Site 0701)

    Santiago, Region M. de Santiago, Chileno site contact published

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)

    Santiago, Region M. de Santiago, Chileno site contact published

  • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504)

    Madrid, Madrid, Comunidad de, Spainno site contact published

  • Département clinique de médecine de laboratoire du CHUM ( Site 0104)

    Montreal, Quebec, Canadano site contact published

  • Fundacion Arturo Lopez Perez ( Site 0700)

    Santiago, Region M. de Santiago, Chileno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0At the end of Cycle 1 (each cycle is 21 days)

    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.

  • Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 60 months

    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.

  • Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)Up to approximately 60 months

    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.