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

NCT ID: NCT05853367

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2028-02-12

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Solid Tumors Advanced Solid Tumors

Keywords

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Programmed Cell Death-1 (PD1, PD-1) Programmed Death-Ligand 1 (PDL1, PD-L1) Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-0472

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.

Group Type EXPERIMENTAL

MK-0472

Intervention Type DRUG

Oral Administration

MK-0472 + Pembrolizumab

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group Type EXPERIMENTAL

MK-0472

Intervention Type DRUG

Oral Administration

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

MK-0472 + MK-1084

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation.

Group Type EXPERIMENTAL

MK-0472

Intervention Type DRUG

Oral Administration

MK-1084

Intervention Type DRUG

Oral Administration

Interventions

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MK-0472

Oral Administration

Intervention Type DRUG

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

MK-1084

Oral Administration

Intervention Type DRUG

Other Intervention Names

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MK-3475 Keytruda®

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Northwestern Memorial Hospital ( Site 0002)

Chicago, Illinois, United States

Site Status RECRUITING

The University of Louisville, James Graham Brown Cancer Center ( Site 0004)

Louisville, Kentucky, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

Hackensack, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0005)

New Brunswick, New Jersey, United States

Site Status RECRUITING

Princess Margaret Cancer Centre ( Site 0101)

Toronto, Ontario, Canada

Site Status RECRUITING

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

Montreal, Quebec, Canada

Site Status RECRUITING

Jewish General Hospital ( Site 0104)

Montreal, Quebec, Canada

Site Status RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0701)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Fundacion Arturo Lopez Perez ( Site 0700)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0702)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Rambam Health Care Campus ( Site 0304)

Haifa, , Israel

Site Status RECRUITING

Shaare Zedek Medical Center ( Site 0303)

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 0301)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0300)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 0302)

Tel Aviv, , Israel

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 0400)

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501)

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status RECRUITING

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

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron ( Site 0500)

Barcelona, , Spain

Site Status RECRUITING

Hospital Virgen del Rocio ( Site 0503)

Seville, , Spain

Site Status RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

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

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status RECRUITING

Ospedale Regionale Bellinzona e Valli ( Site 0200)

Bellinzona, Canton Ticino, Switzerland

Site Status RECRUITING

Countries

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United States Canada Chile Israel Poland Spain Switzerland

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26116&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

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MK-0472-001

Identifier Type: OTHER

Identifier Source: secondary_id

2024-516006-32-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1310-1179

Identifier Type: REGISTRY

Identifier Source: secondary_id

0472-001

Identifier Type: -

Identifier Source: org_study_id