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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

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱 Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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
Has measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
Has archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided
Who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
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 prior to randomization.
Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before intervention allocation/randomization
Has adequate organ function

Exclusion Criteria

Exclusion Criteria:

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled significant cardiovascular disease or cerebrovascular disease
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the start of study intervention
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has active infection requiring systemic therapy
Has concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA) infection

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    180 participants