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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат MK-3120
  IV infusion

Первичные конечные точки

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 43 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 42 months]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator [Срок оценки: Up to approximately 72 months]
• Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator [Срок оценки: Up to approximately 72 months]
• Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator [Срок оценки: Up to approximately 72 months]
• Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator [Срок оценки: Up to approximately 72 months]
• Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC) [Срок оценки: At specified time points up to approximately 43 months]
• AUC of MK-3120 Total Antibody (TAb) [Срок оценки: At specified time points up to approximately 43 months]
• AUC of MK-3120 Free Payload [Срок оценки: At specified time points up to approximately 43 months]
• Maximum Concentration (Cmax) of MK-3120 ADC [Срок оценки: At specified time points up to approximately 43 months]
• Cmax of MK-3120 TAb [Срок оценки: At specified time points up to approximately 43 months]
• Cmax of MK-3120 Free Payload [Срок оценки: At specified time points up to approximately 43 months]
• Minimum Concentration (Cmin) of MK-3120 ADC [Срок оценки: At specified time points up to approximately 43 months]
• Cmin of MK-3120 TAb [Срок оценки: At specified time points up to approximately 43 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• 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

Китай · 5 центров

• Peking University First Hospital ( Site 0180) — Пекин
• Chongqing Cancer Hospital ( Site 0186) — Чунцин
• Hunan Cancer Hospital ( Site 0181) — Чанша
• The First Hospital of Jilin University ( Site 0185) — Changchun
• West China Hospital Sichuan University ( Site 0187) — Чэнду

Чили · 4 центра

• 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

Франция · 4 центра

• 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

Нидерланды · 4 центра

• 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

Польша · 4 центра

• 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 центра

• 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

Испания · 4 центра

• 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 центра

• 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

Израиль · 3 центра

• Rambam Health Care Campus ( Site 0082) — Haifa
• Rabin Medical Center ( Site 0081) — Petah Tikva
• Sheba Medical Center ( Site 0080) — Ramat Gan

Япония · 3 центра

• 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

Тайвань · 3 центра

• Chi Mei Medical Center ( Site 0162) — Tainan
• National Cheng Kung University Hospital ( Site 0161) — Tainan
• National Taiwan University Hospital ( Site 0160) — Taipei

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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