A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

Официальное название

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Обзор

The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.

Вмешательства

• Препарат JNJ-78278343
  JNJ-78278343 will be administered.
• Препарат JNJ-87189401
  JNJ-87189401 will be administered.
• Препарат Apalutamide
  Apalutamide will be administered.
• Препарат Lutetium Lu-177 Vipivotide Tetraxetan
  Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
• Препарат JNJ-101556143
  JNJ-101556143 will be administered.

Первичные конечные точки

• Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) [Срок оценки: Up to 21 days after first combination dose of study drugs]
• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to 4 years 8 months]

Вторичные конечные точки (7)

• Serum Concentrations of JNJ-87189401 and JNJ-78278343 [Срок оценки: Up to 4 years 8 months]
• Plasma Concentration of JNJ-101556143 [Срок оценки: Up to 4 years 8 months]
• Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 [Срок оценки: Up to 4 years 8 months]
• Objective Response Rate (ORR) [Срок оценки: Up to 4 years 8 months]
• Radiographic Progression-Free Survival (rPFS) [Срок оценки: Up to 4 years 8 months]
• Prostate Specific Antigen (PSA) Response Rate [Срок оценки: Up to 4 years 8 months]
• Duration of Response (DOR) [Срок оценки: Up to 4 years 8 months]

Критерии участия

Критерии включения

• Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
• Measurable or evaluable disease per PCWG3 criteria
• Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Критерии исключения

• History of an autoimmune disease within the 12 months prior to signing consent
• Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

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 · 11 центров

• University of Colorado Anschutz Medical Campus — Aurora
• Emory University Winship Cancer Institute — Atlanta
• University Of Minnesota — Minneapolis
• START New Jersey — East Brunswick
• Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York
• Oregon Health And Science University — Portland
• Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia
• Tennessee Oncology — Nashville
• … и ещё 3 центра

Франция · 3 центра

• Institut Bergonie — Bordeaux
• Centre Leon Berard — Lyon
• Institut Gustave Roussy — Villejuif

Австралия · 2 центра

• Greenslopes Private Hospital — Greenslopes
• Peter MacCallum Cancer Centre — Melbourne

Китай · 1 центр

• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Япония · 1 центр

• The Cancer Institute Hospital of JFCR — Tokyo

Идентификаторы

NCT: NCT06095089 · CR109330 · 87189401PCR1001 · 2023-504063-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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