A Study of JNJ-1761981 in Participants With Solid Tumors

Официальное название

Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors

Обзор

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.

Вмешательства

• Препарат JNJ-1761981
  JNJ-1761981 will be administered intratumorally.
• Препарат Cetrelimab
  Cetrelimab will be administered intravenously.

Первичные конечные точки

• Part 1: Number of Participants with Adverse Events (AE) by Severity [Срок оценки: Up to approximately 2 years 10 months]
• Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs) [Срок оценки: Up to 28 days]
• Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure [Срок оценки: Up to approximately 2 years 10 months]
• Part 1: Number of Participants who Received Planned Total Dose per Level [Срок оценки: Up to approximately 28 days]
• Part 2: Administered Tumor Response Rate [Срок оценки: Up to approximately 2 years 10 months]

Вторичные конечные точки (9)

• Parts 1 and 2: Plasma Concentration of Free and Total Platinum [Срок оценки: Up to approximately 2 years 10 months]
• Part 1: Administered Tumor Response Rate [Срок оценки: Up to approximately 2 years 10 months]
• Parts 1 and 2: Administered Tumor Duration of Response [Срок оценки: Up to approximately 2 years 10 months]
• Parts 1 and 2: Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years 10 months]
• Parts 1 and 2: Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years 10 months]
• Parts 1 and 2: Duration of Response (DOR) [Срок оценки: Up to approximately 2 years 10 months]
• Part 2: Number of Participants with Adverse Events (AE) by Severity [Срок оценки: Up to approximately 2 years 10 months]
• Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure [Срок оценки: Up to approximately 2 years 10 months]
• Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose [Срок оценки: Up to approximately 2 years 10 months]

Критерии участия

Критерии включения

• Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
• Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \[NCCN\] guidelines) and whose disease has progressed after standard therapy
• Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
• Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
• A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later

Критерии исключения

• Active symptomatic disease involvement of the central nervous system
• Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)
• Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
• Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
• Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection

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

• Mayo Clinic in Florida — Jacksonville
• Mayo Clinic Rochester — Rochester
• Montefiore Medical Center — The Bronx
• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07525141 · 1761981STM1001 · 1761981STM1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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