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Идёт набор NCT07466160

A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors

Фаза I / Фаза II С лечением Solid Tumor

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: 7MW3711, JS207, Cisplatin, Carboplatin.
Кому может быть актуально
Состояния в реестре: Solid Tumor. Базовые параметры: 18 лет — 75 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
Китай
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 Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors

Обзор

This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.

Подробное описание

A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients With Advanced Solid Tumors.

Вмешательства

  • Препарат 7MW3711
    7MW3711 will be administered as IV infusion.
  • Препарат JS207
    JS207 will be administered as IV infusion.
  • Препарат Cisplatin
    Cisplatin will be administered as IV infusion.
  • Препарат Carboplatin
    Carboplatin will be administered as IV infusion.

Первичные конечные точки

  • Incidence and severity of adverse events (AEs) [Срок оценки: Up to approximately 2 years]
  • Maximum tolerate dose（MTD) [Срок оценки: Up to approximately 2 years]
  • Recommended Expansion Dose (RED) [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (9)
  • Area Under the Concentration-time Curve (AUC) [Срок оценки: Up to approximately 2 years]
  • Maximum concentration (Cmax) [Срок оценки: Up to approximately 2 years]
  • Plasma clearance (CL) [Срок оценки: Up to approximately 2 years]
  • Half-life (t1/2) [Срок оценки: Up to approximately 2 years]
  • Time to peak drug concentration (Tmax) [Срок оценки: Up to approximately 2 years]
  • Investigator-assessed progression-free survival (PFS) [Срок оценки: Up to approximately 2 years]
  • Overall survival (OS) [Срок оценки: Up to approximately 2 years]
  • Investigator-assessed disease control rate (DCR) [Срок оценки: Up to approximately 2 years]
  • Immunogenicity [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of at least 3 months as assessed by the Investigator.
  • Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.
  • Measurable or evaluable disease by RECIST v1.1.
  • Have adequate hematopoietic, renal and hepatic functions.
  • Men or women willing to use adequate contraceptive measures throughout the study.

Критерии исключения

  • Have other prior malignancies within 3 years before the first administration.
  • Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
  • Have significant, uncontrolled, or active cardiovascular disease.
  • Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
  • Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0.
  • Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
  • Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
  • Prior treatment with B7-H3 targeted agents.
  • Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
  • Pregnant, or nursing females.

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

Китай · 1 центр
  • Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT07466160 · 7MW3711-CP202

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗