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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

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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