MK-2010 with Sac-TMT in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the safety and tolerability of MK-2010 given with sacituzumab tirumotecan in participants with advanced solid tumors that have limited treatment options. The study includes additional medications to manage potential reactions, and assesses whether the combination can be tolerated by patients. Eligible participants have good performance status and adequate organ function, with specific requirements for HIV, HBV, and HCV status. Key exclusions include recent anticancer therapy, recent locoregional treatment, ongoing anticoagulation, and a prior grade 3+ immune-related adverse event from immunotherapy. Locations include sites in the United States, Hong Kong, and Switzerland.

Why it matters

Who can join: the full rules

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 it's running

• START San Antonio ( Site 0220)
  San Antonio, Texas, United States Recruiting
• Queen Mary Hospital ( Site 2300)
  Hong Kong, Hong Kong Recruiting
• Ospedale Regionale Bellinzona e Valli ( Site 1102)
  Bellinzona, Canton Ticino, Switzerland Recruiting
• Cantonal Hospital St.Gallen ( Site 1100)
  Sankt Gallen, Switzerland Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.