Идёт набор NCT06178614
A Study of JNJ-87890387 for Advanced Solid Tumors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: JNJ-87890387.
- Кому может быть актуально
- Состояния в реестре: Neoplasms, Advanced Solid Tumors. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Франция, Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors
Обзор
The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).
Вмешательства
- Препарат JNJ-87890387
JNJ-87890387 will be administered.
Первичные конечные точки
- Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) [Срок оценки: Up to first 21 days after administration of the first full treatment dose]
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to 2 years 9 months]
Вторичные конечные точки (10)
- Part 1 and Part 2: Serum Concentration of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Accumulation Ratio of JNJ-87890387 [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Objective Response Rate (ORR) [Срок оценки: Up to 2 years 9 months]
- Part 1 and Part 2: Duration of Response (DOR) [Срок оценки: Up to 2 years 9 months]
Критерии участия
Критерии включения
- Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma
- Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (>) 2\*upper limit of normal (ULN) during screening
- All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
- Be willing and able to adhere to the lifestyle restrictions specified in this protocol.
Критерии исключения
- Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for > 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[<=\]10 milligrams \[mg\] prednisone or equivalent) for at least 2 weeks prior to start of study treatment
- Toxicity from prior anticancer therapy that has not resolved to Grade <=1 (except alopecia, vitiligo, Grade <=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
- History of Grade greater than or equal to (>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.
- History of solid organ or hematologic stem cell transplantation
- Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Start Midwest — Grand Rapids
- Sarah Cannon Research Institute — Nashville
Франция · 2 центра
- Centre Leon Berard — Lyon
- Institut Gustave Roussy — Villejuif
Испания · 2 центра
- Hosp Univ Vall D Hebron — Barcelona
- Hosp. Univ. 12 de Octubre — Madrid
Идентификаторы
NCT: NCT06178614 · CR109339 · 87890387STM1001 · 2023-505358-16-00