Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of MK-2010 in Combination With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Advanced Solid Tumors

Study Identifier:
MK-2010-003
CT.gov Identifier:
NCT07785609
EudraCT Identifier:
202652548121
EU Trial (CTIS) Number:
2026-525481-21-00
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

Considering participating in a START clinical trial?

Get Started

Study 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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1: Safety Lead-In Cohort
Read More
Drug: Participants will receive MK-2010 in combination with sac-TMT.
Drug: Drug: Acetaminophen (or equivalent)
Drug: Administered as a premedication per the approved product label
Drug: Drug: Dexamethasone (or equivalent)
Drug: Drug: Epinephrine
Drug: Administered for emergency use per the approved product label
Drug: Drug: Histamine H1 Receptor Antagonist
Drug: Drug: Histamine H2 Receptor Antagonist
Drug: Drug: MK-2010
Drug: Administered as an intravenous (IV) infusion
Drug: Other Names: LM-299
Drug: Drug: Sacituzumab tirumotecan
Drug: Administered as an IV infusion
Drug: Other Names: sac-TMT, MK-2870, SKB264
Drug: Drug: Steroid mouthwash (dexamethasone or equivalent)
Drug: Administered orally per the approved product label as a rescue medication
Drug: EXPERIMENTAL: Part 2: Signal-Finding Cohorts
Drug: Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor