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Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)

RecruitingPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Malignant Neoplasm

Interventions: MK-4884

Countries: United States, Israel, Japan, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (6)

San Antonio, Texas, United States
Haifa, Israel
Petah Tikva, Israel
Chūō, Tokyo, Japan
Sankt Gallen, Canton of St. Gallen, Switzerland
Bellinzona, Canton Ticino, Switzerland