Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

Официальное название

A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy

Обзор

The goal of this clinical trial is to learn if drug Sac-TMT works to treat Thymic Carcinoma. It will also learn about the safety of Sac-TMT. The main questions it aims to answer are: * How effective is drug Sac-TMT in treating Thymic Carcinoma? * What adverse events (AEs) do participants have when taking drug Sac-TMT? Participants will: * Progress after at least one platinum-based chemotherapy treatment. * Take drug Sac-TMT every 2 weeks. * Take tumor response assessments every 6 weeks.

Вмешательства

• Препарат Sacituzumab tirumotecan
  Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.

Первичные конечные точки

• ORR [Срок оценки: From enrollment to the end of treatment at 24 months]

Вторичные конечные точки (4)

• PFS [Срок оценки: From enrollment to the end of treatment at 24 months]
• OS [Срок оценки: From enrollment to the end of treatment at 24 months]
• Incidence and severity of AEs and SAEs, and abnormal laboratory values. [Срок оценки: From enrollment to the end of treatment at 24 months]
• DCR [Срок оценки: From enrollment to the end of treatment at 24months]

Критерии участия

Критерии включения

• Males or females aged ≥ 18 to ≤ 75 years at the time of signing the Informed Consent Form;
• Participants with histologically or cytologically confirmed thymic carcinoma, and locally advanced or metastatic thymic carcinoma who are not suitable for curative intent therapy;
• Participants with advanced thymic carcinoma who have progressed after at least one prior platinum-based chemotherapy;
• Able to provide a tumor tissue sample at the time of or after the diagnosis of locally advanced or metastatic tumor;
• At least one measurable target lesion that has not received radiotherapy according to RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Expected survival ≥ 12 weeks;
• Adequate organ and bone marrow function.

Критерии исключения

• Participants with histologically or cytologically confirmed thymoma or thymic neuroendocrine tumor;
• Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases;
• Participants with other malignant tumors within 3 years prior to the first dose;
• Presence of any of conditions or risk factors related to cardiovascular and cerebrovascular diseases;
• Uncontrolled systemic disease as judged by the investigator;
• History of interstitial lung disease/noninfectious pneumonitis requiring steroid therapy;
• Clinically severe pulmonary impairment due to lung disorder;
• Presence of active hepatitis B or hepatitis C;
• Known active tuberculosis;
• Known hypersensitivity to the study drug or any of its components.

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

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT07324629 · SKB264-II-17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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