A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

Официальное название

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

Обзор

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.

Вмешательства

• Препарат JNJ-87704916
  JNJ-87704916 will be administered as an intratumoral injection.
• Препарат Cetrelimab
  Cetrelimab will be administered.
• Препарат Standard of Care PD(L)-1
  Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Первичные конечные точки

• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [Срок оценки: Up to 5 years]
• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: From first dose up to 100 days after last dose of study treatment (up to 5 years)]

Вторичные конечные точки (8)

• Parts 1 and 2: Percentage of Participants With Objective Response (OR) [Срок оценки: Up to 5 years]
• Parts 1 and 2: Percentage of Participants With Disease Control (DC) [Срок оценки: Up to 5 years]
• Parts 1 and 2: Duration of Response (DOR) [Срок оценки: Up to 5 years]
• Part 2: Progression Free Survival (PFS) [Срок оценки: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)]
• Part 2: Overall Survival (OS) [Срок оценки: From treatment initiation until death due to any cause (up to 5 years)]
• Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter [Срок оценки: Up to 5 years]
• Parts 1 and 2: Payload Concentrations of JNJ-87704916 [Срок оценки: Up to 2 years]
• Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
• Have at least 1 injectable tumor
• Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
• A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
• Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy

Критерии исключения

• Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
• Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
• Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
• History of solid organ or hematologic stem cell transplantation
• Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
• History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• NYU Langone Health — New York
• Fox Chase Cancer Center — Philadelphia
• UPMC Cancer Centers — Pittsburgh
• MD Anderson Cancer Center — Houston

Испания · 3 центра

• Hosp Univ Vall D Hebron — Barcelona
• Hosp Univ Fund Jimenez Diaz — Madrid
• Hosp Univ Hm Sanchinarro — Madrid

Канада · 2 центра

• Toronto General Hospital — Toronto
• Centre Hospitalier de l'Universite de Montreal — Montreal

Франция · 1 центр

• Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT06311578 · 87704916LUC1001 · 2023-506495-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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