NCT07785609 · Merck Sharp & Dohme LLC
A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
MK-2010
Administered as an intravenous (IV) infusion
BIOLOGICAL
Sacituzumab tirumotecan
Administered as an IV infusion
DRUG
Histamine H1 Receptor Antagonist
Administered as a premedication per the approved product label
DRUG
Histamine H2 Receptor Antagonist
Administered as a premedication per the approved product label
DRUG
Acetaminophen (or equivalent)
Administered as a premedication per the approved product label
DRUG
Dexamethasone (or equivalent)
Administered as a premedication per the approved product label
DRUG
Steroid mouthwash (dexamethasone or equivalent)
Administered orally per the approved product label as a rescue medication
DRUG
Epinephrine
Administered for emergency use per the approved product label
Primary outcome measures
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 27 months
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.
Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)
Time frame: Up to approximately 28 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Number of Participants Who Discontinued Study Intervention Due to an AE
Time frame: Up to approximately 24 months
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.
Objective Response Rate (ORR)
Time frame: Up to approximately 60 months
ORR is defined as a confirmed complete response (CR: Disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2026 · Source of record for eligibility and locations