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NCT Number: NCT07600749

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

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.

Recruiting

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rambam Health Care Campus ( Site 0051), Haifa, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-4884

Drug

Oral Administration

Primary outcomes

  1. Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

    Time frame: Up to approximately 21 days

    DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.

  2. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 39 months

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with experience an AE will be reported.

  3. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 39 months

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE will be reported.

Secondary outcomes

  1. Area Under the Concentration-Time Curve (AUC) of MK-4884

    Time frame: At designated timepoints (up to approximately 15 days)

    Blood samples will be collected to determine the AUC of MK-4884 in plasma.

  2. Maximum Plasma Concentration (Cmax) of MK-4884

    Time frame: At designated timepoints (up to approximately 15 days)

    Blood samples will be collected to determine the Cmax of MK-4884 in plasma.

  3. Trough Plasma Concentration (Ctrough) of MK-4884

    Time frame: At designated timepoints (up to approximately 39 months)

    Blood samples will be collected to determine the Ctrough of MK-4884 in plasma.

  4. Time to Maximum Plasma Concentration (Tmax) of MK-4884

    Time frame: At designated timepoints (up to approximately 15 days)

    Blood samples will be collected to determine the Tmax of MK-4884 in plasma.

  5. Apparent Terminal Half-life (t½) of MK-4884

    Time frame: At designated timepoints (up to approximately 15 days)

    Blood samples will be collected to determine the t1/2 of MK-4884 in plasma.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants With Advanced/Metastatic Solid Tumors

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 22, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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