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Studieoverzicht

Study name: A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

Histology NSCLC, all subtypesSCLC
Tumor stage Stage III - IV
NCT Id NCT06818643
Host / recruiting site 1 Radboud UMC Enrollment Recruiting
Therapy line Later line (≥2L)
PD-L1 expression Negative: <1%Low: 1 - 49%High: ≥50%
Design

Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
Intervention

BIOLOGICAL: MK-3120 - IV infusion
Key outcome parameters

  • Number of Participants Who Experience an Adverse Event (AE)

  • Number of Participants Who Discontinue Study Treatment Due to an AE
Key inclusion criteria
  • Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
  • If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
  • If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • If hepatitis C virus (HCV) infected, must have undetectable HCV viral load
Key exclusion criteria
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has uncontrolled significant cardiovascular disease or cerebrovascular disease
  • 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 pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
  • Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active infection requiring systemic therapy, with exceptions
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has HBV or HCV infection
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