A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants with Advanced/Metastatic Solid Tumors

未提供0 个研究点目标入组 6 人开始时间: 待定

适应症

试验速览

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•Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
•Colorectal carcinoma (CRC) ; Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features) ; Nonsquamous non-small cell lung cancer (NSCLC) ; Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
•Has measurable disease by RECIST 1.1
•Has adequate organ function
•Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
•Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
•Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

•Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
•Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
•Has a serious nonhealing wound, ulcer, or bone fracture
•Has an active infection(s) requiring systemic therapy
•HIV-infected participants with 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
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
•Has a history of stem cell/solid organ transplant
•Has not adequately recovered from major surgery

发起方

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