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Advanced Solid TumorsPhase 1/2NCT07876128

A Clinical Trial of MK-2750 in Participants With Advanced Solid Tumors (MK-2750-002)

A Phase 1/2 study testing MK-2750, 5-HT3 serotonin receptor antagonist and NK-1 receptor antagonist in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

MK-2750 is a trial medicine designed to treat certain solid tumors. MK-2750 is a type of treatment called an antibody drug conjugate (ADC). ADCs attach to a protein on cancer cells and deliver medicine to destroy those cells. 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-2750, 5-HT3 serotonin receptor antagonist and NK-1 receptor antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
16 Nov 2026to 30 May 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 histologically or cytologically confirmed advanced or metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC); advanced or metastatic NSCLC; or advanced, unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC)
  • Has histologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma or squamous cell carcinoma of the esophagus; advanced or metastatic adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or gastric/stomach that is considered incurable by local therapies; or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies
  • Has provided archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
  • If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
  • If hepatitis B surface antigen (HBsAg)-positive, has received HBV antiviral therapy for at least 4 weeks and has undetectable hepatitis B virus (HBV) viral load
  • If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
  • Has adequate organ function

Who cannot join

  • Is HIV-infected with history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to allocation/randomization
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids; current diagnosis of ILD; or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
Show all 11Show fewer
  • Has active infection requiring systemic therapy other than those permitted in the protocol
  • 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 uncontrolled significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval by Fridericia (QTcF) to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
  • Has not adequately recovered from major surgery or has ongoing surgical complications

About this study

Official title: A Phase 1b/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of MK-2750 in Participants With Advanced Solid Tumors

MK-2750 is a trial medicine designed to treat certain solid tumors. MK-2750 is a type of treatment called an antibody drug conjugate (ADC). ADCs attach to a protein on cancer cells and deliver medicine to destroy those cells.

The goals of this trial are to learn:

  • About the safety of MK-2750 and if participants tolerate it. Tolerate means participants will receive trial treatment in the trial unless they need to stop it due to health problems.
  • How many participants have cancer respond (get smaller or go away) to MK-2750
Being tested
MK-2750, 5-HT3 serotonin receptor antagonist, NK-1 receptor antagonist, Corticosteroid, Steroid mouthwash (dexamethasone or equivalent)
Medical subject headings
Neoplasms

What participants receive

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

  • MK-2750Biological

    Administered as an intravenous (IV) infusion

  • 5-HT3 serotonin receptor antagonistDrug

    Administered as a premedication per the approved product label

  • NK-1 receptor antagonistDrug

    Administered as a premedication per the approved product label

  • CorticosteroidDrug

    Administered as a premedication per the approved product label

  • Steroid mouthwash (dexamethasone or equivalent)Drug

    Administered orally per the approved product label as a rescue medication

Study groups in NCT07876128
Study groupRoleWhat they receive
Part 1: Dose Comparison CohortExperimentalParticipants will receive MK-2750
Receives: Biological: MK-2750; Drug: 5-HT3 serotonin receptor antagonist; Drug: NK-1 receptor antagonist; Drug: Corticosteroid; Drug: Steroid mouthwash (dexamethasone or equivalent)
Part 2: Signal-Finding CohortsExperimentalParticipants will receive MK-2750
Receives: Biological: MK-2750; Drug: 5-HT3 serotonin receptor antagonist; Drug: NK-1 receptor antagonist; Drug: Corticosteroid; Drug: Steroid mouthwash (dexamethasone or equivalent)

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 any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 2 years

  2. Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 2 years

  3. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who have 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) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator will be presented.

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Duration of Response (DOR)

    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by investigator, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  2. Maximum Plasma Concentration (Cmax) of MK-2750 Free Payload

    Blood samples will be collected to determine Cmax of MK-2750 Free Payload.

    Measured: Predose and at designated time points up to approximately 2 years

  3. Cmax of MK-2750 Total Antibodies (TAb)

    Blood samples will be collected to determine Cmax of MK-2750 Total Antibodies.

    Measured: Predose and at designated time points up to approximately 2 years

  4. Cmax of MK-2750 Antibody-Drug Conjugate (ADC)

    Blood samples will be collected to determine Cmax of MK-2750 Antibody-Drug Conjugate.

    Measured: Predose and at designated time points up to approximately 2 years

  5. Trough Concentration (Ctrough) of MK-2750 Free Payload

    Blood samples will be collected to determine Ctrough of MK-2750 Free Payload.

    Measured: Predose and at designated time points up to approximately 2 years

  6. Ctrough of MK-2750 TAb

    Blood samples will be collected to determine Ctrough of MK-2750 Total Antibodies.

    Measured: Predose and at designated time points up to approximately 2 years

  7. Ctrough of MK-2750 ADC

    Blood samples will be collected to determine Ctrough of MK-2750 Antibody-Drug Conjugate.

    Measured: Predose and at designated time points up to approximately 2 years

Timeline

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

  1. First posted15 Oct 2026
  2. Study start16 Nov 2026 (estimated)
  3. Primary completion12 Apr 2029 (estimated)
  4. Study completion30 May 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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876128
Sponsor's protocol ID
2750-002
Other IDs
U1111-1331-4501, 2025-524637-21-00, 2025
Status last verified
Sep 2026
First submitted
9 Oct 2026
Last updated
15 Oct 2026
Results posted
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-2750, 5-HT3 serotonin receptor antagonist and NK-1 receptor antagonist in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC.

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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2 years). The study lists 3 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 NCT07876128.

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 15 Oct 2026.

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