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Recruiting
NCT07600749
Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
Conditions: Malignant Neoplasm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 120
Sponsor: Merck Sharp & Dohme LLC
Location: NEXT Oncology ( Site 0151) San Antonio Texas
Summary
Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.
The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.
Eligibility Criteria
Inclusion Criteria:
* 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 Response Evaluation Criteria In Solid Tumors 1.1 (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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07600749). StuddyBuddy aggregates publicly available trial information.