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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Drug: MK-4884

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve (AUC) of MK-4884	Blood samples will be collected to determine the AUC of MK-4884 in plasma.	At designated timepoints (up to approximately 15 days)
Maximum Plasma Concentration (Cmax) of MK-4884	Blood samples will be collected to determine the Cmax of MK-4884 in plasma.	At designated timepoints (up to approximately 15 days)
Trough Plasma Concentration (Ctrough) of MK-4884	Blood samples will be collected to determine the Ctrough of MK-4884 in plasma.	At designated timepoints (up to approximately 39 months)
Time to Maximum Plasma Concentration (Tmax) of MK-4884	Blood samples will be collected to determine the Tmax of MK-4884 in plasma.	At designated timepoints (up to approximately 15 days)
Apparent Terminal Half-life (t½) of MK-4884	Blood samples will be collected to determine the t1/2 of MK-4884 in plasma.	At designated timepoints (up to approximately 15 days)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 4, 2029
• Study Completion (Estimated): October 4, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 4884-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No