SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

Официальное название

A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Вмешательства

• Препарат SKB264+SKB118
  Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

Первичные конечные точки

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [Срок оценки: From enrollment to the end of treatment at 24 months]
• ORR(objective response rate) [Срок оценки: From enrollment to the end of treatment at 24 months]

Вторичные конечные точки (4)

• DCR(Disease control rate ) [Срок оценки: From enrollment to the end of treatment at 24 months]
• DOR(duration of response ) [Срок оценки: From enrollment to the end of treatment at 24 months]
• PFS(progression-free survival) [Срок оценки: From enrollment to the end of treatment at 24 months]
• OS (overall survival) [Срок оценки: From enrollment to the end of treatment at 24 months]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC
• Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
• Provide a tumor tissue sample.
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Adequate bone marrow, liver, kidney, and coagulation function.
• Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.

Критерии исключения

• Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
• Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
• Uncontrolled systemic disease as judged by the investigator.
• Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
• Presence of other moderate to severe lung disorders.
• History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
• Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
• Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
• Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• Known hypersensitivity to the study drug or any of its components.
• Pregnant or lactating women.

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 · 2 центра

• Jilin Cancer Hospital — Jilin City
• Shanghai East Hospital, Tongji University — Шанхай

Идентификаторы

NCT: NCT07697586 · SKB264-II-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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