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NCT05853367 | RECRUITING | Metastatic Solid Tumors

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

Merck Sharp & Dohme LLC

Brief Summary:

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.

Condition or disease

Metastatic Solid Tumors

Advanced Solid Tumors

Intervention/treatment

MK-0472

Pembrolizumab

MK-1084

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 178 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.
Actual Study Start Date : 2023-07-06
Estimated Primary Completion Date : 2028-02-12
Estimated Study Completion Date : 2028-02-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 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
    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
      • * 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
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Location Details

NCT05853367

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Northwestern Memorial Hospital ( Site 0002)

Chicago, Illinois, United States, 60611

RECRUITING

United States, Kentucky

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

Louisville, Kentucky, United States, 40202

RECRUITING

United States, New Jersey

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

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey ( Site 0005)

New Brunswick, New Jersey, United States, 08901

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre ( Site 0101)

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

Hospital Center of the University of Montreal-Unit for Innovative Therapies (site 0100)

Montréal, Quebec, Canada, H2X 0A9

RECRUITING

Chile, Region M. Of Santiago

Bradfordhill ( Site 0702)

Santiago., Region M. Of Santiago, Chile, 8420383

RECRUITING

Chile, Region M. Of Santiago

Saga Clinical Studies Center (Site 0701)

Santiago, Region M. Of Santiago, Chile, 7500653

RECRUITING

Chile, Region M. Of Santiago

Arturo Lopez Perez Foundation (Site 0700)

Santiago, Region M. Of Santiago, Chile, 7500921

RECRUITING

Chile, Region M. Of Santiago

CLINICADELA CATOLICA CLINICADELA CENTER (Site 0703)

Santiago, Region M. Of Santiago, Chile, 8330034

RECRUITING

Israel,

Rambam Health Care Campus ( Site 0304)

Haifa, Israel, 3109601

RECRUITING

Israel,

Shaare Zedek Medical Center ( Site 0303)

Jerusalem, Israel, 9103102

RECRUITING

Israel,

Rabin Medical Center ( Site 0301)

Heels of a tip, Israel, 4941492

RECRUITING

Israel,

Sheba Medical Center ( Site 0300)

Ramat Gain, Israel, 5265601

RECRUITING

Israel,

Sourasky Medical Center ( Site 0302)

Tel Aviv, Israel, 6423906

RECRUITING

Poland, Masovian

National Oncology Institute Maria Sklodowska -Curie - State Research Institute in Warsaw (Site 0401)

Warsaw, Masovian Voivodeship, Poland, 02-781

RECRUITING

Poland, Pomeranian

University Clinical Center (Site 0400)

Gdansk, Pomeranian, Poland, 80-214

RECRUITING

Spain, Cataluna

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

L'Hospitalet de Llobregat, Cataluna, Spain, 08907

RECRUITING

Spain,

Vall d'Hebron University Hospital (Site 0500)

Barcelona, Spain, 08035

RECRUITING

Spain,

Virgen del Rocio Hospital (Site 0503)

Sevilla, Spain, 41013

RECRUITING

Switzerland, Genetic

Geneva University Hospitals (HUG) (site 0202)

Geneva, Geneva, Switzerland, 1211

RECRUITING

Switzerland, Sankt Gallen

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

St.Gallen, Sankt Gallen, Switzerland, 9000

RECRUITING

Switzerland, Ticino

Bellinzona and Valli Regional Hospital (Site 0200)

Bellinzona, Ticino, Switzerland, 6500