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

NCT06818643 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 3120-0022024-516817-19-00U1111-1311-1904jRCT2031250198
• Study Type: interventional
• Target: 270
• Locations: 11 countries
• Sites: 42

Brief 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.

Conditions

Advanced Solid Tumors; Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.

  Up to approximately 43 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

  Up to approximately 42 months

Secondary Outcomes (13)

• Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator

  Up to approximately 72 months

• Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator

  Up to approximately 72 months

• Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator

  Up to approximately 72 months

• Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator

  Up to approximately 72 months

• Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC)

  At specified time points up to approximately 43 months

Study Arms (2)

Arm 1 Dose level 1

EXPERIMENTAL

Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm.

Biological: MK-3120

Arm 2 Dose level 2

EXPERIMENTAL

Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm.

Biological: MK-3120

Interventions

MK-3120 BIOLOGICAL

IV infusion

Also known as: SKB410

Arm 1 Dose level 1; Arm 2 Dose level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (42)

The University of Alabama at Birmingham ( Site 1005)

Birmingham, Alabama, 35249, United States

RECRUITING

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

Miami, Florida, 33136, United States

RECRUITING

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

Hackensack, New Jersey, 07601, United States

RECRUITING

Virginia Commonwealth University ( Site 1008)

Richmond, Virginia, 23219, United States

RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0033)

Santiago, Region M. de Santiago, 7500653, Chile

RECRUITING

FALP ( Site 0031)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0032)

Santiago, Region M. de Santiago, 8330032, Chile

RECRUITING

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Peking University First Hospital ( Site 0180)

Beijing, Beijing Municipality, 100034, China

RECRUITING

Chongqing Cancer Hospital ( Site 0186)

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Hunan Cancer Hospital ( Site 0181)

Changsha, Hunan, 410013, China

RECRUITING

The First Hospital of Jilin University ( Site 0185)

Changchun, Jilin, 130021, China

RECRUITING

West China Hospital Sichuan University ( Site 0187)

Chengdu, Sichuan, 610041, China

RECRUITING

Institut Paoli Calmettes ( Site 0053)

Marseille, Bouches-du-Rhone, 13273, France

RECRUITING

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

Rennes, Ille-et-Vilaine, 35000, France

RECRUITING

Centre Oscar Lambret ( Site 0051)

Lille, Nord, 59000, France

RECRUITING

Gustave Roussy ( Site 0050)

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Rambam Health Care Campus ( Site 0082)

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center ( Site 0081)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0080)

Ramat Gan, 5265601, Israel

RECRUITING

National Cancer Center Hospital East ( Site 0190)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 0192)

Koto, Tokyo, 135-8550, Japan

RECRUITING

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

Osaka, 541-8567, Japan

RECRUITING

Radboudumc ( Site 0091)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

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

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc ( Site 0093)

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Erasmus Medisch Centrum ( Site 0092)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Seoul National University Hospital ( Site 0150)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 0151)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 0153)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 0152)

Seoul, 06351, South Korea

RECRUITING

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

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)

Barcelona, Catalonia, 08036, Spain

RECRUITING

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

Madrid, Madrid, Comunidad de, 28040, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 0114)

Málaga, 29016, Spain

RECRUITING

Chi Mei Medical Center ( Site 0162)

Tainan, Tainan, 71004, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 0161)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 0160)

Taipei, 10002, Taiwan

RECRUITING

Ankara Bilkent Şehir Hastanesi. ( Site 0131)

Çankaya, Ankara, 06800, Turkey (Türkiye)

RECRUITING

Ankara University Health Practice and Research Hospitals ( Site 0134)

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri ( Site 0130)

Ankara, 6230, Turkey (Türkiye)

RECRUITING

Koc University, School of Medicine ( Site 0133)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 25, 2028
• Study Completion (Estimated): March 25, 2031
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (4); KR (4); CL (4); ES (4); FR (4); TU (4); CN (5); JP (3); TW (3); US (4); IL (3)