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Advanced Solid TumorsPhase 1/2NCT06818643

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

A Phase 1/2 study testing MK-3120 in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 49 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Malignant Neoplasm
What is being tested?
MK-3120
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
49 sitesin 12 countries
Study dates
25 Mar 2025to 25 Mar 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

49 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

49 sites in 12 countries

United States7 sites, 7 recruiting

  • NEXT Oncology ( Site 1010)

    Austin, Texas, 78758

    Study Coordinator, 737-610-5202

    Recruiting

  • The University of Alabama at Birmingham ( Site 1005)

    Birmingham, Alabama, 35249

    Study Coordinator, 205-934-4199

    Recruiting

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

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5900

    Recruiting

  • NEXT Oncology ( Site 1011)

    Houston, Texas, 77054

    Study Coordinator, 832-384-7912

    Recruiting

  • NEXT Oncology ( Site 1012)

    Irving, Texas, 75039

    Study Coordinator, 972-893-8800

    Recruiting

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

    Miami, Florida, 33136

    Study Coordinator, 305-243-5302

    Recruiting

  • Virginia Commonwealth University ( Site 1008)

    Richmond, Virginia, 23219

    Study Coordinator, 804-828-7999

    Recruiting

Other trials in United States

China5 sites, 1 recruiting

  • Peking University First Hospital ( Site 0180)

    Beijing, Beijing Municipality, 100034

    Active, not recruiting

  • The First Hospital of Jilin University ( Site 0185)

    Changchun, Jilin, 130021

    Active, not recruiting

  • Hunan Cancer Hospital ( Site 0181)

    Changsha, Hunan, 410013

    Study Coordinator, 073188651900

    Recruiting

  • West China Hospital Sichuan University ( Site 0187)

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • Chongqing Cancer Hospital ( Site 0186)

    Chongqing, Chongqing Municipality, 400030

    Active, not recruiting

Other trials in China

Chile4 sites, 4 recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0033)

    Santiago, Region M. de Santiago, 7500653

    Study Coordinator, +56991612199

    Recruiting

  • Fundación Arturo López Pérez ( Site 0031)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0032)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, +56934331806

    Recruiting

  • Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

Other trials in Chile

France4 sites, 3 recruiting

  • Centre Oscar Lambret ( Site 0051)

    Lille, Nord, 59000

    Study Coordinator, +33320295959

    Recruiting

  • Institut Paoli Calmettes ( Site 0053)

    Marseille, Bouches-du-Rhone, 13273

    Study Coordinator, +33491223789

    Recruiting

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

    Rennes, Ille-et-Vilaine, 35000

    Active, not recruiting

  • Gustave Roussy ( Site 0050)

    Villejuif, Val-de-Marne, 94800

    Study Coordinator, +33 (0)1 42 11 42 11

    Recruiting

Other trials in France

Netherlands4 sites, 4 recruiting

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

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31 20 512 2446

    Recruiting

  • Amsterdam UMC, locatie VUmc ( Site 0093)

    Amsterdam, North Holland, 1081HV

    Study Coordinator, +31 20 444 4875

    Recruiting

  • Radboudumc ( Site 0091)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31 24 361 0353

    Recruiting

  • Erasmus Medisch Centrum ( Site 0092)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +31 10 704 0252

    Recruiting

Other trials in Netherlands

Poland4 sites, 4 recruiting

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48943488930

    Recruiting

  • Pratia MCM Krakow ( Site 0106)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122954100

    Recruiting

  • Pratia Poznan ( Site 0105)

    Poznan, Greater Poland Voivodeship, 60-192

    Study Coordinator, +48506969916

    Recruiting

  • Narodowy Instytut Onkologii ( Site 0100)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225463381

    Recruiting

Other trials in Poland

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital ( Site 0150)

    Seoul, 03080

    Study Coordinator, +82220720795

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 0151)

    Seoul, 03722

    Study Coordinator, 82-2-393-3652

    Recruiting

  • Asan Medical Center ( Site 0153)

    Seoul, 05505

    Study Coordinator, 02-3010-3266

    Recruiting

  • Samsung Medical Center ( Site 0152)

    Seoul, 06351

    Study Coordinator, +82234103438

    Recruiting

Other trials in South Korea

Spain4 sites, 3 recruiting

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)

    Barcelona, Catalonia, 08036

    Active, not recruiting

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

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932603261

    Recruiting

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

    Madrid, Madrid, Comunidad de, 28040

    Study Coordinator, +34915504800x2805

    Recruiting

  • Hospital Universitario Virgen de la Victoria ( Site 0114)

    Málaga, 29016

    Study Coordinator, +34951032508

    Recruiting

Other trials in Spain

Turkey (Türkiye)4 sites, 3 recruiting

  • Ankara University Health Practice and Research Hospitals ( Site 0134)

    Ankara, 06620

    Study Coordinator, +90 312 595 71 39

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 0130)

    Ankara, 6230

    Study Coordinator, +90 312 305 43 30

    Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 0131)

    Çankaya, Ankara, 06800

    Active, not recruiting

  • Koc University, School of Medicine ( Site 0133)

    Istanbul, 34010

    Study Coordinator, 0212 467 87 00.

    Recruiting

Other trials in Turkey (Türkiye)

Israel3 sites

  • Rambam Health Care Campus ( Site 0082)

    Haifa, 3109601

    Active, not recruiting

  • Rabin Medical Center ( Site 0081)

    Petah Tikva, 4941492

    Active, not recruiting

  • Sheba Medical Center ( Site 0080)

    Ramat Gan, 5265601

    Active, not recruiting

Other trials in Israel

Japan3 sites, 2 recruiting

  • National Cancer Center Hospital East ( Site 0190)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 0192)

    Koto, Tokyo, 135-8550

    Active, not recruiting

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

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

Other trials in Japan

Taiwan3 sites

  • Chi Mei Medical Center ( Site 0162)

    Tainan, Tainan, 71004

    Active, not recruiting

  • National Cheng Kung University Hospital ( Site 0161)

    Tainan, 704

    Active, not recruiting

  • National Taiwan University Hospital ( Site 0160)

    Taipei, 10002

    Active, not recruiting

Other trials in Taiwan

About this study

Official title: 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.

Being tested
MK-3120
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-3120Biological

    Also called SKB410

    IV infusion

Study groups in NCT06818643
Study groupRoleWhat they receive
Arm 1 Dose level 1ExperimentalParticipants receive MK-3120 at dose level 1 as per the schedule specified in the arm.
Receives: Biological: MK-3120
Arm 2 Dose level 2ExperimentalParticipants receive MK-3120 at dose level 2 as per the schedule specified in the arm.
Receives: Biological: MK-3120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 19 months

  2. 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.

    Measured: Up to approximately 18 months

Secondary outcomes (1)

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

    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.

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start25 Mar 2025
  3. Primary completion8 Feb 2028 (estimated)
  4. Study completion25 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06818643
Sponsor's protocol ID
3120-002
Other IDs
2024-516817-19-00, U1111-1311-1904, jRCT2031250198
Status last verified
Oct 2026
First submitted
7 Feb 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MK-3120 in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 49 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, China, Chile, France, Netherlands and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 19 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06818643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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