Recruiting
Phase 2

MK-2010 & Sac-TMT

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07785609

Conditions

Advanced Solid Tumors

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-2010

Sacituzumab tirumotecan

Histamine H1 Receptor Antagonist

Histamine H2 Receptor Antagonist

Acetaminophen (or equivalent)

Study Details

Brief summary:

Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. The cancer may not be able to be treated with surgery or radiation, which uses beams of intense energy (like X-rays) to shrink or get rid of tumors. Some cancers may not have gone away or came back after previous treatment. MK-2010, the trial treatment, is designed to help the immune system fight cancer.

This trial will look at MK-2010 when given with another trial treatment called sacituzumab tirumotecan (sac-TMT). Sac-TMT is an antibody-drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

The goals of this trial are to learn:

  • About the safety of MK-2010 with sac-TMT and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
  • How many participants who receive MK-2010 with sac-TMT have the cancer respond to treatment. Respond means the cancer gets smaller or goes away.

Conditions

Advanced Solid Tumors

Malignant Neoplasm

Study ID

NCT07785609

Start date

Oct 9, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Sep 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks
  • If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
  • Has adequate organ function

Exclusion Criteria:

  • If prior anticancer therapy is allowed, participants are excluded if they received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before allocation
  • Has received prior locoregional therapy within 2 weeks of start of study intervention, or has ongoing locoregional treatment-related toxicities
  • Is currently receiving any anticoagulants
  • Was discontinued from prior immunotherapy due to a Grade ≥3 immune-related adverse event (irAE)
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • 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 active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • Active or ongoing stomatitis and/or mucositis of any grade
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis
  • Has history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
  • 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 history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications
  • Has clinically significant hemoptysis, hematemesis, or tumor bleeding within 4 weeks before the first dose of study intervention
  • Has any clinically significant or life-threatening bleeding event that occurred within 3 months prior to the first dose of the study intervention
  • Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
  • Has any history of myocarditis or cardiomyopathy
  • Has a current or history of severe cardiovascular and cerebrovascular diseases

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Safety Lead-In Cohort

Participants will receive MK-2010 in combination with sac-TMT.

experimental: Part 2: Signal-Finding Cohorts

Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1.

Interventions

MK-2010

Administered as an intravenous (IV) infusion

Sacituzumab tirumotecan

Administered as an IV infusion

Histamine H1 Receptor Antagonist

Administered as a premedication per the approved product label

Histamine H2 Receptor Antagonist

Administered as a premedication per the approved product label

Acetaminophen (or equivalent)

Administered as a premedication per the approved product label

Dexamethasone (or equivalent)

Administered as a premedication per the approved product label

Steroid mouthwash (dexamethasone or equivalent)

Administered orally per the approved product label as a rescue medication

Epinephrine

Administered for emergency use per the approved product label

Primary outcome measure

  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]
  • Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only) [ Time Frame: Up to approximately 28 days ]
  • Number of Participants Who Discontinued Study Intervention Due to an AE [ Time Frame: Up to approximately 24 months ]
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 60 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

START San Antonio ( Site 0220)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-593-5265

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.