A Study of SKB518 in Patients With Lung Cancer

Официальное название

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer

Обзор

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Вмешательства

• Препарат SKB518
  SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
• Препарат Tislelizumab
  Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
• Препарат Carboplatin
  Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles

Первичные конечные точки

• AE [Срок оценки: Up to 24 months]
• ORR in specific arms [Срок оценки: Up to 24 months]
• PFS in specific arm [Срок оценки: Up to 24 months]

Вторичные конечные точки (5)

• PFS in specific arms [Срок оценки: Up to 24 months]
• DOR in specific arms [Срок оценки: Up to 24 months]
• OS [Срок оценки: Up to 24 months]
• Pharmacokinetics [Срок оценки: Up to 24 months]
• Immunogenicity [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
• Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
• At least one measurable tumor lesion per RECIST v1.1.
• Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
• Expected survival period ≥ 12 weeks.
• The function of important organs meets the requirements of the protocol.

Критерии исключения

• Symptomatic or uncontrolled cardiovascular disease
• History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
• Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
• Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

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 · 17 центров

• Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center — Шэньчжэнь
• Cancer Hospital of Guangxi Medical University — Nanning
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Hubei Cancer Hospital — Ухань
• Renmin Hospital of Wuhan University — Ухань
• Xiangyang Central Hospital — Xiangyang
• Hunan Cancer Hospital — Чанша
• Jiangxi Cancer Hospital — Nanchang
• … и ещё 9 центров

Идентификаторы

NCT: NCT07019675 · SKB518-II-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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