The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Официальное название

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Обзор

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Вмешательства

• Препарат SHR-9839
  Weekly fixed dose injection of SHR-9839

Первичные конечные точки

• Maximum tolerated dose (MTD) or maximum administered dose (MAD) [Срок оценки: On the first day of each week,4 weeks is a treatment cycle]
• Recommended Phase 2 dose (RP2D) [Срок оценки: From Day 1 to 90 days after last dose]
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) [Срок оценки: From Day 1 to 90 days after last dose]

Вторичные конечные точки (9)

• PK parameter: Tmax of SHR-9839 [Срок оценки: approximately 10 months]
• PK parameter: Cmax of SHR-9839 [Срок оценки: approximately 10 months]
• PK parameter: AUC0-t of SHR-9839 [Срок оценки: Approximately 10 months]
• PK parameter: AUC0-∞ of SHR-9839 [Срок оценки: Approximately 10 months]
• Immunogenicity of SHR-9839 [Срок оценки: Approximately 12 months]
• Overall response rate (ORR) [Срок оценки: Approximately within 36 months]
• Duration of response (DoR) [Срок оценки: Approximately within 36 months]
• Disease control rate (DCR) [Срок оценки: Approximately within 36 months]
• Progression-free survival (PFS) [Срок оценки: Approximately within 36 months]

Критерии участия

Критерии включения

• Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
• Have at least one measurable tumor lesion per RECIST v1.1;
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• Adequate bone marrow and organ function;
• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Критерии исключения

• Patients with active central nervous system metastases or meningeal metastases;
• Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
• History of serious cardiovascular and cerebrovascular diseases;
• Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
• Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

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

• Zhejiang Tumor Hospital — Ханчжоу

Идентификаторы

NCT: NCT05836948 · SHR-9839-I-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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