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Идёт набор NCT06079112

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

Фаза I / Фаза II С лечением Advanced Urothelial Carcinoma

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: 9MW2821, Toripalimab.
Кому может быть актуально
Состояния в реестре: Advanced Urothelial Carcinoma. Базовые параметры: 18 лет — 80 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 Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

Обзор

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Вмешательства

  • Препарат 9MW2821
    1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
  • Препарат Toripalimab
    240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.

Первичные конечные точки

  • incidence of AE/SAE [Срок оценки: Up to 24 months]
Вторичные конечные точки (8)
  • Objective Response Rate, ORR [Срок оценки: Up to 24 months]
  • Duration of Response, DOR [Срок оценки: Up to 24 months]
  • Time To Response, TTR [Срок оценки: Up to 24 months]
  • Disease Control Rate, DCR [Срок оценки: Up to 24 months]
  • Progression-Free Survival, PFS [Срок оценки: Up to 24 months]
  • Overall Survival, OS [Срок оценки: Up to 24 months]
  • Pharmacokinetics parameter [Срок оценки: Up to 12 months]
  • Immunogenicity parameter [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

  • Sign and date the informed consent form e approved by independent ethics committe.
  • Male or female subjects aged 18 to 80 years (including 18 and 80 years).
  • ECOG status of 0 or 1.
  • Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
  • Subjects have received at least 1 line advanced standard therapy or were not treated before
  • Subjects must submit tumor tissues for test
  • Life expectancy of ≥ 12 weeks.
  • Subjects must have measurable lesions according to RECIST (version 1.1).
  • Adequate organ functions
  • Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
  • Subjects are willing to follow study procedures.

Критерии исключения

  • Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
  • Major surgery within 28 days prior to first dose of study drug.
  • PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
  • Previous treatment with ADCs conjugated with MMAE payload.
  • Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
  • Peripheral neuropathy Grade ≥ 2.
  • Poorly controlled blood sugar.
  • Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
  • Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
  • Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
  • Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
  • Poorly controlled central nervous system metastases.
  • Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
  • History of drug abuse or mental illness.
  • Known allergic sensitivity to any of the ingredients of the study drug.
  • Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
  • History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
  • Any live vaccines within 4 weeks before first dose of study drug or during the study.
  • Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
  • History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
  • Other conditions unsuitable into the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06079112 · 9MW2821-2023-CP104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗