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

October 26, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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, 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
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • Fundación Arturo López Pérez ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Active, not recruiting
        • Peking University First Hospital ( Site 0180)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Active, not recruiting
        • Chongqing Cancer Hospital ( Site 0186)
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0181)
        • Contact:
          • Study Coordinator
          • Phone Number: 073188651900
    • Jilin
      • Changchun, Jilin, China, 130021
        • Active, not recruiting
        • The First Hospital of Jilin University ( Site 0185)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital Sichuan University ( Site 0187)
  • 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
        • Active, not recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)
    • 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
        • Active, not recruiting
        • Rambam Health Care Campus ( Site 0082)
      • Petah Tikva, Israel, 4941492
        • Active, not recruiting
        • Rabin Medical Center ( Site 0081)
      • Ramat Gan, Israel, 5265601
        • Active, not recruiting
        • Sheba Medical Center ( Site 0080)
  • 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
        • Active, not recruiting
        • Cancer Institute Hospital of JFCR ( Site 0192)
  • 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
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Recruiting
        • Pratia Poznan ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +48506969916
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: +48122954100
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225463381
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: +48943488930
  • 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
        • Active, not recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)
    • 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
        • Active, not recruiting
        • National Cheng Kung University Hospital ( Site 0161)
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • National Taiwan University Hospital ( Site 0160)
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Active, not recruiting
        • Chi Mei Medical Center ( Site 0162)
  • 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
        • Active, not recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 0131)
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 19 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 19 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 18 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 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 48 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 48 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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