Recruiting
Phase 1

MK-4884

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07600749

Conditions

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-4884

Study Details

Brief 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.

Conditions

Malignant Neoplasm

Study ID

NCT07600749

Start date

Jun 18, 2026

Status verified date

Sep, 2026

Completion date

Oct 4, 2029

Anticipated

Primary completion date

Oct 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

MK-4884

Oral Administration

Primary outcome measure

  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 21 days ]
  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 39 months ]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 39 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

NEXT Oncology ( Site 0151)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-568-4397

Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0002)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Study Coordinator

514-890-8000

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.