Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
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
- Malignant Neoplasm
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
NEXT Oncology ( Site 0151)
San Antonio, Texas 78229
San Antonio, Texas 78229
Contact:
Study Coordinator
210-568-4397
Study Coordinator
210-568-4397
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC