NCT07600749PHASE1Recruiting
Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
Merck Sharp & Dohme LLC
Start Date
6/18/2026
Completion Date
10/4/2029
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
Age Range: 18 years to No maximum
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
Interventions
DRUG
MK-4884
Conditions
Malignant Neoplasm
Locations
NEXT Oncology ( Site 0151)
San Antonio, Texas 78229
United States
Rambam Health Care Campus ( Site 0051)
Haifa, 3109601
Israel
Rabin Medical Center ( Site 0053)
Petah Tikva, 4941492
Israel
National Cancer Center Hospital ( Site 0201)
Chūō, Tokyo 104-0045
Japan
Cantonal Hospital St.Gallen ( Site 0101)
Sankt Gallen, Canton of St. Gallen 9000
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0104)
Bellinzona, Canton Ticino 6500
Switzerland