A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors

Обзор

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.

Вмешательства

• Препарат SHR-7787 injection
  Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.

Первичные конечные точки

• Maximum tolerated dose [Срок оценки: first dose of study medication up to 21 days]
• Recommended phase II dose [Срок оценки: first dose of study medication up to 21 days]
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Срок оценки: from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks]
• Incidence of Dose Limited Toxicity (DLT) [Срок оценки: from first dose to 4 weeks]

Вторичные конечные точки (6)

• Tmax [Срок оценки: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
• Cmax [Срок оценки: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
• AUC0-t [Срок оценки: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
• t1/2 [Срок оценки: predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose]
• ADA [Срок оценки: 0.5 hour before first dose through study completion, an average of 1 year]
• ORR [Срок оценки: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]

Критерии участия

Критерии включения

• Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
• Patients with unresectable recurrent or metastatic solid tumors;
• There is at least one lesion could be measured;
• An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Adequate organ functions as defined;
• Life expectancy ≥3 months.

Критерии исключения

• Patients with known active central nervous system (CNS) metastases;
• Subjects who had other malignancy in five years before the first dose;
• Patients with tumor-related pain that cannot be controlled as determined;
• Patients with serious cardiovascular and cerebrovascular diseases;
• Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
• Patients with Severe infections;
• History of immunodeficiency;
• History of autoimmune diseases;
• Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy
• Active infection;
• Pregnant or nursing women;
• Known history of serious allergic reactions to the investigational product or its main ingredients.

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 Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT06605222 · SHR-7787-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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