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Набор скоро начнётся NCT07566247

A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor

Фаза I С лечением Advanced Malignant 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: AK150.
Кому может быть актуально
Состояния в реестре: Advanced Malignant Solid Tumors. 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 Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor

Обзор

This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.

Вмешательства

  • Препарат AK150
    IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment

Первичные конечные точки

  • Number of participants with a Dose Limiting Toxicity (DLT) [Срок оценки: During the first 4 weeks]
  • Number of participants with adverse events (AEs) [Срок оценки: From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.]
Вторичные конечные точки (5)
  • Serum PK concentration of AK150 [Срок оценки: From pre-dose to the end of the last dose, an average of 6 months.]
  • The immunogenicity of AK150 [Срок оценки: From pre-dose to 30 days post end of treatment]
  • Overall response rate (ORR) [Срок оценки: Up to 12 year.]
  • Progression-Free Survival(PFS) [Срок оценки: Up to 1 year]
  • Disease control rate(DCR) [Срок оценки: Up to 1 year.]

Критерии участия

Критерии включения

  • Be able to understand and voluntarily sign the written informed consent form.
  • Aged of ≥ 18 years and ≤75 years.
  • ECOG PS 0 or 1.
  • The expected lifespan is ≥3 months.
  • Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate organ function.
  • Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

Критерии исключения

  • Having other active malignancies within 3 years.
  • Currently participating in another interventional clinical study.
  • Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
  • Having received any treatment targeting CSF-1R, ILT2 and ILT4..
  • Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.
  • Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
  • Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
  • Participants with active autoimmune diseases requiring systemic treatment within 2 years.
  • Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.
  • Known to be positive for HIV and other infections.
  • Live attenuated vaccines were received within 28 days.

13\. Participants with a history of mental illness and incapacitated or limited capacity.

14\. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • Fujian Cancer Hospital — Фучжоу
  • Dongguan People's Hospital — Дунгуань
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07566247 · AK150-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗