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

May 6, 2026 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile ( Site 0032)
        • Contact:
          • Study Coordinator
          • Phone Number: +56934331806
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital ( Site 0180)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-83572211
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital ( Site 0186)
        • Contact:
          • Study Coordinator
          • Phone Number: 023-65079277
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0181)
        • Contact:
          • Study Coordinator
          • Phone Number: 073188651900
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University ( Site 0185)
        • Contact:
          • Study Coordinator
          • Phone Number: 0431-88783330
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital Sichuan University ( Site 0187)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85421141
  • France
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13273
        • Recruiting
        • Institut Paoli Calmettes ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491223789
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: +33299253196
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Centre Oscar Lambret ( Site 0051)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320295959
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy ( Site 0050)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 (0)1 42 11 42 11
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0082)
        • Contact:
          • Study Coordinator
          • Phone Number: 97247776234
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0081)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378110
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0080)
        • Contact:
          • Study Coordinator
          • Phone Number: 9725304498
  • Japan
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 0190)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 0192)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 0091)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 24 361 0353
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 20 512 2446
      • Amsterdam, North Holland, Netherlands, 1081HV
        • Recruiting
        • Amsterdam UMC, locatie VUmc ( Site 0093)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 20 444 4875
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum ( Site 0092)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 10 704 0252
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0150)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720795
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 0151)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-393-3652
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-3010-3266
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 0152)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103438
  • Spain
      • Málaga, Spain, 29016
        • Recruiting
        • Hospital Universitario Virgen de la Victoria ( Site 0114)
        • Contact:
          • Study Coordinator
          • Phone Number: +34951032508
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0113)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932603261
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932274208
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915504800x2805
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 0161)
        • Contact:
          • Study Coordinator
          • Phone Number: 88662353535
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital ( Site 0160)
        • Contact:
          • Study Coordinator
          • Phone Number: 886223123456
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center ( Site 0162)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662812811x53571
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 305 43 30
      • Ankara, Turkey (Türkiye), 06620
        • Recruiting
        • Ankara University Health Practice and Research Hospitals ( Site 0134)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 595 71 39
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koc University, School of Medicine ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 0212 467 87 00.
    • Ankara
      • Çankaya, Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 0131)
        • Contact:
          • Study Coordinator
          • Phone Number: +905555306271
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • The University of Alabama at Birmingham ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 205-934-4199
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-243-5302
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5900
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Oncology ( Site 1010)
        • Contact:
          • Study Coordinator
          • Phone Number: 737-610-5202
      • Houston, Texas, United States, 77054
        • Recruiting
        • NEXT Oncology ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-384-7912
      • Irving, Texas, United States, 75039
        • Recruiting
        • NEXT Oncology ( Site 1012)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-893-8800
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-828-7999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 Dose level 1
Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm.
Biological: MK-3120
IV infusion
Other Names:
  • SKB410
Experimental: Arm 2 Dose level 2
Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm.
Biological: MK-3120
IV infusion
Other Names:
  • SKB410

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 43 months
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
Time Frame: Up to approximately 42 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator
Time Frame: Up to approximately 72 months
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator per RECIST 1.1.
Up to approximately 72 months
Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator
Time Frame: Up to approximately 72 months
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator per RECIST 1.1 will be presented.
Up to approximately 72 months
Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator
Time Frame: Up to approximately 72 months
PFS is defined as the time from the first dose of study treatment to the first documented PD or death due to any cause, whichever occurs first will be assessed by the investigator using RECIST 1.1. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator per RECIST 1.1 will be presented.
Up to approximately 72 months
Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator
Time Frame: Up to approximately 72 months
OS is defined as the time from the first dose of study treatment to death due to any cause as assessed by the investigator per RECIST 1.1 will be presented.
Up to approximately 72 months
Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC)
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the AUC of MK-3120 ADC.
At specified time points up to approximately 43 months
AUC of MK-3120 Total Antibody (TAb)
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the AUC of MK-3120 TAb
At specified time points up to approximately 43 months
AUC of MK-3120 Free Payload
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the AUC of MK-3120 free payload.
At specified time points up to approximately 43 months
Maximum Concentration (Cmax) of MK-3120 ADC
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmax of MK-3120 ADC.
At specified time points up to approximately 43 months
Cmax of MK-3120 TAb
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmax of MK-3120 TAb.
At specified time points up to approximately 43 months
Cmax of MK-3120 Free Payload
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmax of MK-3120 free payload.
At specified time points up to approximately 43 months
Minimum Concentration (Cmin) of MK-3120 ADC
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmin of MK-3120 ADC.
At specified time points up to approximately 43 months
Cmin of MK-3120 TAb
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmin of MK-3120 TAb.
At specified time points up to approximately 43 months
Cmin of MK-3120 Free Payload
Time Frame: At specified time points up to approximately 43 months
Blood samples will be collected to determine the Cmin of MK-3120 free payload.
At specified time points up to approximately 43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

October 25, 2028

Study Completion (Estimated)

March 25, 2031

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3120-002
  • U1111-1311-1904 (Registry Identifier: UTN)
  • 2024-516817-19-00 (Registry Identifier: EU CT)
  • jRCT2031250198 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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