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

NCT07600749 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 4884-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

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

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

  Up to approximately 21 days

• Number of Participants Who Experience an Adverse Event (AE)

  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.

  Up to approximately 39 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  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.

  Up to approximately 39 months

Secondary Outcomes (5)

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

  At designated timepoints (up to approximately 15 days)

• Maximum Plasma Concentration (Cmax) of MK-4884

  At designated timepoints (up to approximately 15 days)

• Trough Plasma Concentration (Ctrough) of MK-4884

  At designated timepoints (up to approximately 39 months)

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

  At designated timepoints (up to approximately 15 days)

• Apparent Terminal Half-life (t½) of MK-4884

  At designated timepoints (up to approximately 15 days)

Study Arms (2)

MK-4884 Dose Escalation Schedule A

EXPERIMENTAL

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

MK-4884 Dose Escalation Schedule B

EXPERIMENTAL

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

Interventions

MK-4884 DRUG

Oral Administration

MK-4884 Dose Escalation Schedule A; MK-4884 Dose Escalation Schedule B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 4, 2029
• Study Completion (Estimated): October 4, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share