A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors

Обзор

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.

Вмешательства

• Препарат SHR-1681
  SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: 12 months.]
• Maximum administered dose (MAD) [Срок оценки: 12 months.]
• Recommended Phase 2 dose (RP2D) [Срок оценки: 12 months.]
• Incidence and severity of adverse events (AEs) [Срок оценки: Approximately 3 years.]
• Incidence and severity of serious adverse events (SAEs) [Срок оценки: Approximately 3 years.]

Вторичные конечные точки (10)

• Time to maximum concentration (Tmax) of SHR-1681 [Срок оценки: Approximately 3 years.]
• Maximum concentration (Cmax) of SHR-1681 [Срок оценки: Approximately 3 years.]
• Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681 [Срок оценки: Approximately 3 years.]
• Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681 [Срок оценки: Approximately 3 years.]
• Anti-SHR-1681 antibody (ADA) of SHR-1681 [Срок оценки: Approximately 3 years.]
• Overall response rate (ORR) [Срок оценки: Approximately 3 years.]
• Duration of response (DoR) [Срок оценки: Approximately 3 years.]
• Disease control rate (DCR) [Срок оценки: Approximately 3 years.]
• Progression-free survival (PFS) [Срок оценки: Approximately 3 years.]
• Overall survival (OS) [Срок оценки: Approximately up to 5 years after the last subject enrolled.]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
• Subjects 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 score of 0-1;
• Life expectancy ≥ 3 months;
• Adequate bone marrow and organ function.

Критерии исключения

• Subjects with active central nervous system metastases or meningeal metastases;
• History of serious cardiovascular and cerebrovascular diseases;
• Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
• Severe infection within 4 weeks prior to the first dose;
• Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
• 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

• Shanghai Dongfang Hospital — Шанхай

Идентификаторы

NCT: NCT06737731 · SHR-1681-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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