招募中 NCT07785609

MK-2010 聯合 Sacituzumab Tirumotecan (Sac-TMT) 用於實體瘤參與者的臨床試驗 (MK-2010)

肉瘤Phase IIIII 期IV 期

研究人員正在尋找治療某些類型晚期實體瘤的新方法。實體瘤是指主要位於身體器官和組織中的癌症,而非血液或其他體液中的癌症。晚期可能意味著癌症已擴散至附近或身體其他部位。該癌症可能無法以手術或放射治療(利用高能量射束,如X光,來縮小或消除腫瘤)來治療。

適應症:Advanced Solid Tumors、Malignant Neoplasm

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年11月5日。