A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)

NCT07785609 | Not Yet Recruiting Phase 2 FDA Drug

• 4 other identifiers: 2010-003MK-2010-003U1111-1334-82532026-525481-21-00
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Malignant Neoplasm; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to approximately 27 months

• Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)

  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.

  Up to approximately 28 days

• 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.

  Up to approximately 24 months

• Objective Response Rate (ORR)

  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).

  Up to approximately 60 months

Secondary Outcomes (5)

• Duration of Response (DOR)

  Up to approximately 60 months

• Area Under the Concentration-Time Curve (AUC) of MK-2010

  Predose and at designated time points post-dose (up to approximately 24 months)

• Trough Concentration (Ctrough) of MK-2010

  Predose and at designated time points post-dose (up to approximately 24 months)

• Maximum Plasma Concentration (Cmax) of MK-2010

  Predose and at designated time points post-dose (up to approximately 24 months)

• Incidence of Antidrug Antibodies (ADA) to MK-2010

  Predose and at designated time points post-dose (up to approximately 24 months)

Study Arms (2)

Part 1: Safety Lead-In Cohort

EXPERIMENTAL

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

Biological: MK-2010; Biological: Sacituzumab tirumotecan; Drug: Histamine H1 Receptor Antagonist; Drug: Histamine H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent); Drug: Epinephrine

Part 2: Signal-Finding Cohorts

EXPERIMENTAL

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

Biological: MK-2010; Biological: Sacituzumab tirumotecan; Drug: Histamine H1 Receptor Antagonist; Drug: Histamine H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent); Drug: Epinephrine

Interventions

MK-2010 BIOLOGICAL

Administered as an intravenous (IV) infusion

Also known as: LM-299

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Sacituzumab tirumotecan BIOLOGICAL

Administered as an IV infusion

Also known as: sac-TMT, MK-2870, SKB264

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Histamine H1 Receptor Antagonist DRUG

Administered as a premedication per the approved product label

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Histamine H2 Receptor Antagonist DRUG

Administered as a premedication per the approved product label

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Acetaminophen (or equivalent) DRUG

Administered as a premedication per the approved product label

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Dexamethasone (or equivalent) DRUG

Administered as a premedication per the approved product label

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Steroid mouthwash (dexamethasone or equivalent) DRUG

Administered orally per the approved product label as a rescue medication

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Epinephrine DRUG

Administered for emergency use per the approved product label

Part 1: Safety Lead-In Cohort; Part 2: Signal-Finding Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Neoplasms

Interventions

Histamine H1 Antagonists; Histamine H2 Antagonists; Acetaminophen; Dexamethasone; Epinephrine

Intervention Hierarchy (Ancestors)

Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share