A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors

Официальное название

An Open-label, Multicenter Phase I/II Study of Safety, Tolerability,Pharmacokinetics and Efficacy of SHR-9803 for Injection in Patients With Advanced Solid Tumors

Обзор

This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.

Вмешательства

• Препарат SHR-9803
  SHR-9803

Первичные конечные точки

• Dose Limited Toxicity（Ia） [Срок оценки: Screening up to the end of phase Ia, an average of 6 months]
• Dose Limited Toxicity (Ib) [Срок оценки: Screening up to the end of phase Ib, an average of 1 year]
• Recommended phase II dose(Ib) [Срок оценки: Screening up to the end of phase Ib, an average of 2 years]
• objective response rate(II) [Срок оценки: Screening up to study completion, an average of 3 year]

Вторичные конечные точки (4)

• Adverse Events, [Срок оценки: Screening up to study completion, an average of 3 year;]
• Disease Control Rate (DCR), [Срок оценки: Screening up to study completion, an average of 3 year]
• Progression-Free Survival (PFS), [Срок оценки: Screening up to study completion, an average of 3 year;]
• Plasma concentration of SHR-9803 [Срок оценки: Screening up to study completion, an average of 3 year;]

Критерии участия

Критерии включения

• Voluntary participation and written informed consent.
• 18-75 years old, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1
• With a life expectancy ≥ 3 months.
• Pathologically diagnosed advanced solid tumor.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow reserve and organ function.
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Критерии исключения

• Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
• Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
• Previous or co-existing malignancies；
• Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
• Have active or prior documented autoimmune disease;
• Have used corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
• With poorly controlled or severe cardiovascular disease;
• A history of interstitial pneumonia/non-infectious pneumonia;
• Severe infection 1 month before the first dose;
• Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
• With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
• Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
• Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
• Received live-attenuated vaccines within 4 weeks prior to the first dose.
• Known to have had an allergic reaction to other monoclonal antibodies.

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

• Harbin Medical University cancer hospital — Харбин

Идентификаторы

NCT: NCT06906731 · SHR-9803-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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