A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

Официальное название

An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

Обзор

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

Вмешательства

• Препарат SHR-4610 Injection
  SHR-4610 injection in different dose.

Первичные конечные точки

• The Dose-Limiting Toxicity (DLT) [Срок оценки: Post-dose at day 1 to the end of treatment visit, about 1 year.]
• The Maximum Tolerated Dose (MTD) [Срок оценки: Post-dose at day 1 to the end of treatment visit, about 1 year.]
• Recommended dosage for Phase II (RP2D) [Срок оценки: Post-dose at day 1 to the end of treatment visit, about 1 year.]
• Incidence and severity of adverse events (AEs) [Срок оценки: Up to 90 days after the last administration.]

Вторичные конечные точки (9)

• Objective Response Rate (ORR) [Срок оценки: From the first administration to the end of treatment visit, about 1 year.]
• Duration of relief (DOR) [Срок оценки: From the first administration to the end of treatment visit, about 1 year.]
• Disease Control Rate (DCR) [Срок оценки: From the first administration to the end of treatment visit, about 1 year.]
• Time to Response (TTR) [Срок оценки: From the first administration to the end of treatment visit, about 1 year.]
• Progression-free survival (PFS) [Срок оценки: From the first administration to the end of treatment visit, about 1 year.]
• Time to the maximum plasma concentration (Tmax) [Срок оценки: From Day 1 pre-dose to 30 days after the last administration.]
• Maximum concentration of SHR-4610 (Cmax) [Срок оценки: From Day 1 pre-dose to 30 days after the last administration.]
• SHR-4610 serum trough concentration (Ctrough) [Срок оценки: From Day 1 pre-dose to 30 days after the last administration.]
• Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t) [Срок оценки: From Day 1 pre-dose to 30 days after the last administration.]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
• Age range: 18-75 years old, both male and female are welcome;
• 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;
• 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.

Критерии исключения

• Patients with active central nervous system metastases or meningeal metastases;
• Systemic antitumor therapy was received 4 weeks before the start of the study;
• Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
• Have poorly controlled or severe cardiovascular disease;
• Subjects with active hepatitis B or active hepatitis C;
• 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

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07231211 · SHR-4610-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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