RecruitingPhase 1Phase 2NCT06818643

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)

A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors


Sponsor

Merck Sharp & Dohme LLC

Enrollment

270 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
  • If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
  • If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • If hepatitis C virus (HCV) infected, must have undetectable HCV viral load

Exclusion Criteria10

  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has uncontrolled significant cardiovascular disease or cerebrovascular disease
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
  • Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active infection requiring systemic therapy, with exceptions
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has HBV or HCV infection

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Interventions

BIOLOGICALMK-3120

IV infusion


Locations(42)

The University of Alabama at Birmingham ( Site 1005)

Birmingham, Alabama, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)

Miami, Florida, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)

Hackensack, New Jersey, United States

Virginia Commonwealth University ( Site 1008)

Richmond, Virginia, United States

Centro de Estudios Clínicos SAGA ( Site 0033)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0031)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0032)

Santiago, Region M. de Santiago, Chile

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)

Santiago, Region M. de Santiago, Chile

Peking University First Hospital ( Site 0180)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 0186)

Chongqing, Chongqing Municipality, China

Hunan Cancer Hospital ( Site 0181)

Changsha, Hunan, China

The First Hospital of Jilin University ( Site 0185)

Changchun, Jilin, China

West China Hospital Sichuan University ( Site 0187)

Chengdu, Sichuan, China

Institut Paoli Calmettes ( Site 0053)

Marseille, Bouches-du-Rhone, France

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)

Rennes, Ille-et-Vilaine, France

Centre Oscar Lambret ( Site 0051)

Lille, Nord, France

Gustave Roussy ( Site 0050)

Villejuif, Val-de-Marne, France

Rambam Health Care Campus ( Site 0082)

Haifa, Israel

Rabin Medical Center ( Site 0081)

Petah Tikva, Israel

Sheba Medical Center ( Site 0080)

Ramat Gan, Israel

National Cancer Center Hospital East ( Site 0190)

Kashiwa, Chiba, Japan

Cancer Institute Hospital of JFCR ( Site 0192)

Koto, Tokyo, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191)

Osaka, Japan

Radboudumc ( Site 0091)

Nijmegen, Gelderland, Netherlands

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090)

Amsterdam, North Holland, Netherlands

Amsterdam UMC, locatie VUmc ( Site 0093)

Amsterdam, North Holland, Netherlands

Erasmus Medisch Centrum ( Site 0092)

Rotterdam, South Holland, Netherlands

Seoul National University Hospital ( Site 0150)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 0151)

Seoul, South Korea

Asan Medical Center ( Site 0153)

Seoul, South Korea

Samsung Medical Center ( Site 0152)

Seoul, South Korea

Institut Català d'Oncologia - L'Hospitalet ( Site 0113)

L'Hospitalet de Llobregat, Barcelona, Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)

Barcelona, Catalonia, Spain

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Virgen de la Victoria ( Site 0114)

Málaga, Spain

Chi Mei Medical Center ( Site 0162)

Tainan, Tainan, Taiwan

National Cheng Kung University Hospital ( Site 0161)

Tainan, Taiwan

National Taiwan University Hospital ( Site 0160)

Taipei, Taiwan

Ankara Bilkent Şehir Hastanesi. ( Site 0131)

Çankaya, Ankara, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals ( Site 0134)

Ankara, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 0130)

Ankara, Turkey (Türkiye)

Koc University, School of Medicine ( Site 0133)

Istanbul, Turkey (Türkiye)

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NCT06818643


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