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Recruiting NCT06818643

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)

Phase I / Phase II Interventional Advanced Solid Tumors 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-3120.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors, 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, Chile, China, France, Israel +7
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 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

Overview

Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

Interventions

  • Biological MK-3120
    IV infusion

Primary outcome measures

  • Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 43 months]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 42 months]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator [Time frame: Up to approximately 72 months]
  • Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator [Time frame: Up to approximately 72 months]
  • Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator [Time frame: Up to approximately 72 months]
  • Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator [Time frame: Up to approximately 72 months]
  • Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC) [Time frame: At specified time points up to approximately 43 months]
  • AUC of MK-3120 Total Antibody (TAb) [Time frame: At specified time points up to approximately 43 months]
  • AUC of MK-3120 Free Payload [Time frame: At specified time points up to approximately 43 months]
  • Maximum Concentration (Cmax) of MK-3120 ADC [Time frame: At specified time points up to approximately 43 months]
  • Cmax of MK-3120 TAb [Time frame: At specified time points up to approximately 43 months]
  • Cmax of MK-3120 Free Payload [Time frame: At specified time points up to approximately 43 months]
  • Minimum Concentration (Cmin) of MK-3120 ADC [Time frame: At specified time points up to approximately 43 months]
  • Cmin of MK-3120 TAb [Time frame: At specified time points up to approximately 43 months]

Eligibility 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

  • 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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • The University of Alabama at Birmingham ( Site 1005) — Birmingham
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003) — Miami
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009) — Hackensack
  • NEXT Oncology ( Site 1010) — Austin
  • NEXT Oncology ( Site 1011) — Houston
  • NEXT Oncology ( Site 1012) — Irving
  • Virginia Commonwealth University ( Site 1008) — Richmond
China · 5 centers
  • Peking University First Hospital ( Site 0180) — Beijing
  • Chongqing Cancer Hospital ( Site 0186) — Chongqing
  • Hunan Cancer Hospital ( Site 0181) — Changsha
  • The First Hospital of Jilin University ( Site 0185) — Changchun
  • West China Hospital Sichuan University ( Site 0187) — Chengdu
Chile · 4 centers
  • Centro de Estudios Clínicos SAGA ( Site 0033) — Santiago
  • FALP ( Site 0031) — Santiago
  • Pontificia Universidad Catolica de Chile ( Site 0032) — Santiago
  • Bradford Hill Centro de Investigaciones Clinicas ( Site 0030) — Santiago
France · 4 centers
  • Institut Paoli Calmettes ( Site 0053) — Marseille
  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 00 — Rennes
  • Centre Oscar Lambret ( Site 0051) — Lille
  • Gustave Roussy ( Site 0050) — Villejuif
Netherlands · 4 centers
  • Radboudumc ( Site 0091) — Nijmegen
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090) — Amsterdam
  • Amsterdam UMC, locatie VUmc ( Site 0093) — Amsterdam
  • Erasmus Medisch Centrum ( Site 0092) — Rotterdam
Poland · 4 centers
  • Pratia Poznan ( Site 0105) — Poznan
  • Pratia MCM Krakow ( Site 0106) — Krakow
  • Narodowy Instytut Onkologii ( Site 0100) — Warsaw
  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104) — Koszalin
South Korea · 4 centers
  • Seoul National University Hospital ( Site 0150) — Seoul
  • Severance Hospital Yonsei University Health System ( Site 0151) — Seoul
  • Asan Medical Center ( Site 0153) — Seoul
  • Samsung Medical Center ( Site 0152) — Seoul
Spain · 4 centers
  • Institut Català d'Oncologia - L'Hospitalet ( Site 0113) — L'Hospitalet de Llobregat
  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0112) — Barcelona
  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111) — Madrid
  • Hospital Universitario Virgen de la Victoria ( Site 0114) — Málaga
Turkey (Türkiye) · 4 centers
  • Ankara Bilkent Şehir Hastanesi. ( Site 0131) — Çankaya
  • Ankara University Health Practice and Research Hospitals ( Site 0134) — Ankara
  • Hacettepe Universite Hastaneleri ( Site 0130) — Ankara
  • Koc University, School of Medicine ( Site 0133) — Istanbul
Israel · 3 centers
  • Rambam Health Care Campus ( Site 0082) — Haifa
  • Rabin Medical Center ( Site 0081) — Petah Tikva
  • Sheba Medical Center ( Site 0080) — Ramat Gan
Japan · 3 centers
  • National Cancer Center Hospital East ( Site 0190) — Kashiwa
  • Cancer Institute Hospital of JFCR ( Site 0192) — Koto
  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191) — Osaka
Taiwan · 3 centers
  • Chi Mei Medical Center ( Site 0162) — Tainan
  • National Cheng Kung University Hospital ( Site 0161) — Tainan
  • National Taiwan University Hospital ( Site 0160) — Taipei

Identifiers

NCT: NCT06818643 · 3120-002 · 2024-516817-19-00 · U1111-1311-1904 · jRCT2031250198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗