問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMK-3120-002
NCT Number(ClinicalTrials.gov Identfier)NCT06818643
Active

2025-01-21 - 2030-12-31

Phase I/II

Recruiting3

ICD-10C69.40

Malignant neoplasm of unspecified ciliary body

ICD-10C69.41

Malignant neoplasm of right ciliary body

ICD-10C69.42

Malignant neoplasm of left ciliary body

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9190.0

Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid

A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    美商默沙東藥廠股份有限公司台灣分公司

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors 、Malignant Neoplasm

Objectives

Primary Objectives:  To evaluate the safety and tolerability of MK-3120 as monotherapy Secondary Objectives:  To evaluate the antitumor activity of MK-3120 by the trial principal investigator using the Objective Response Rate (ORR) as measured by the Responsible Response Standard for Solid Tumors (RECIST) version 1.1.  To evaluate the antitumor activity of MK-3120 by the trial principal investigator using duration of response (DOR), progression-free survival (PFS), and overall survival (OS).  To evaluate the pharmacokinetics (PK) of MK-3120 as monotherapy.

Test Drug

Freeze-dried injection

Active Ingredient

MK-3120

Dosage Form

245

Dosage

20 mg/mL

Endpoints

- Adverse events (AEs)

- Treatment discontinuation due to AEs

Inclution Criteria

Inclusion Criteria:

Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
If hepatitis C virus (HCV) infected, must have undetectable HCV viral load

Exclusion Criteria

Exclusion Criteria:

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has uncontrolled significant cardiovascular disease or cerebrovascular disease
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
Is HIV-positive and has 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
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active infection requiring systemic therapy, with exceptions
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has HBV or HCV infection

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    180 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB