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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07785609
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors
  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-2010 — BIOLOGICAL
    Administered as an intravenous (IV) infusion
  • Sacituzumab tirumotecan — BIOLOGICAL
    Administered as an IV infusion
  • Histamine H1 Receptor Antagonist — DRUG
    Administered as a premedication per the approved product label
  • Histamine H2 Receptor Antagonist — DRUG
    Administered as a premedication per the approved product label
  • Acetaminophen (or equivalent) — DRUG
    Administered as a premedication per the approved product label
  • Dexamethasone (or equivalent) — DRUG
    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
  • Epinephrine — DRUG
    Administered for emergency use per the approved product label

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]

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