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Идёт набор NCT07623356

A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer

Фаза I / Фаза II С лечением Non-Small Cell Lung Cancer

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: AK138D1, Ivonescimab, Carboplatin.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung Cancer. 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 Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.

Подробное описание

This is a multicenter, open-label phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. The phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.

Вмешательства

  • Препарат AK138D1
    Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
  • Препарат Ivonescimab
    Enrolled subjects will receive intravenous infusion (IV) of Ivonescimab according to the dosing regimen specified in their cohort.
  • Препарат Carboplatin
    Enrolled subjects will receive intravenous infusion (IV) of Carboplatin according to the dosing regimen specified in their cohort.

Первичные конечные точки

  • Adverse events (AEs) [Срок оценки: Up to approximately 2 years]
  • Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (7)
  • Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
  • Duration of response (DoR) [Срок оценки: Up to approximately 2 years]
  • Time to response (TTR) [Срок оценки: Up to approximately 2 years]
  • Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
  • Overall Survival (OS) [Срок оценки: Up to approximately 2 years]
  • Pharmacokinetics (PK) characteristics [Срок оценки: Up to approximately 2 years]
  • Anti-drug antibodies (ADA) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • The subject must sign the written informed consent form (ICF) voluntarily;
  • At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Has a life expectancy of ≥ 3 months;
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Has Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer \[AJCC\]).
  • Adequate organ function.

Критерии исключения

  • Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
  • Presence of active central nervous system (CNS) metastases.
  • Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
  • Untreated subjects with active hepatitis B or active hepatitis C;
  • Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
  • Known active syphilis infection;
  • Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
  • Other reasons for ineligibility as evaluated by investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT07623356 · AK138D1-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗