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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-4884 Dose Escalation Schedule A 		Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
  • Drug: MK-4884
    Oral Administration
Experimental
MK-4884 Dose Escalation Schedule B 		Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
  • Drug: MK-4884
    Oral Administration

Recruiting Locations

NEXT Oncology ( Site 0151)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-568-4397

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.