A Phase I/II Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

Study Identifier:
MK3120-002
CT.gov Identifier:
NCT06818643
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-516817-19-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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.

To evaluate the safety and tolerability of MK-3120 monotherapy

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
  • Unspecified Cancer
    • 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.
    I/II
    Sex
    Female & Male
    Age
    18 - 64 Years
    Study Drug
  • Drug: Experimental: Arm 1 Dose level 1
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  • Drug: Experimental: Arm 2 Dose level 2
  • Drug: CFDA:
  • Drug: Chinese common name: MK-3120 for injection
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatmentsIf 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 loadIf hepatitis C virus (HCV) infected, must have undetectable HCV viral load
    Exclusion criteria
    • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel diseaseHas uncontrolled significant cardiovascular disease or cerebrovascular diseaseHas history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healingHas pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainageIs HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's DiseaseKnown additional malignancy that is progressing or has required active treatment within the past 2 yearsKnown active central nervous system (CNS) metastases and/or carcinomatous meningitisActive infection requiring systemic therapy, with exceptionsHistory of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHas HBV or HCV infection

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Unspecified Cancer