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Recruiting NCT07600749

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

Phase I Interventional Malignant Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-4884.
Who it may be relevant to
Registry conditions: Malignant Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Israel, Japan, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug MK-4884
    Oral Administration

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Area Under the Concentration-Time Curve (AUC) of MK-4884 [Time frame: At designated timepoints (up to approximately 15 days)]
  • Maximum Plasma Concentration (Cmax) of MK-4884 [Time frame: At designated timepoints (up to approximately 15 days)]
  • Trough Plasma Concentration (Ctrough) of MK-4884 [Time frame: At designated timepoints (up to approximately 39 months)]
  • Time to Maximum Plasma Concentration (Tmax) of MK-4884 [Time frame: At designated timepoints (up to approximately 15 days)]
  • Apparent Terminal Half-life (t½) of MK-4884 [Time frame: At designated timepoints (up to approximately 15 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 2 centers
  • Rambam Health Care Campus ( Site 0051) — Haifa
  • Rabin Medical Center ( Site 0053) — Petah Tikva
Switzerland · 2 centers
  • Cantonal Hospital St.Gallen ( Site 0101) — Sankt Gallen
  • Ospedale Regionale Bellinzona e Valli ( Site 0104) — Bellinzona
United States · 1 center
  • NEXT Oncology ( Site 0151) — San Antonio
Japan · 1 center
  • National Cancer Center Hospital ( Site 0201) — Chūō

Identifiers

NCT: NCT07600749 · 4884-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗