A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

Официальное название

Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

Обзор

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.

Вмешательства

• Препарат SHR-1826
  SHR-1826
• Препарат SHR-4642
  SHR-4642
• Препарат SHR-9839
  SHR-9839
• Препарат SHR-8068
  SHR-8068
• Препарат Bevacizumab Injection
  Bevacizumab Injection
• Препарат Fluorouracil Injection
  Fluorouracil Injection
• Препарат Calcium Folinate Injection
  Calcium Folinate Injection
• Препарат Adebrelimab Injection
  Adebrelimab Injection
• Препарат Capecitabine tablets
  Capecitabine tablets, oral.

Первичные конечные точки

• RP2D (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• AE (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Objective response rate (ORR) (Phase 2) [Срок оценки: Screening up to study completion, an average of 1 year.]

Вторичные конечные точки (12)

• Objective response rate (ORR) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Disease control rate (DCR) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Duration of response (DoR) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Progression-free survival (PFS) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Overall survival (OS) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Drug Resistant Antibody (ADA) (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Blood concentration of SHR-1826 (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Blood concentration of free toxin SHR169265 (Phase 1) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Disease control rate (DCR) (Phase 2) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Duration of response (DoR) (Phase 2) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Progression-free survival (PFS) (Phase 2) [Срок оценки: Screening up to study completion, an average of 1 year.]
• Overall survival (OS) (Phase 2) [Срок оценки: Screening up to study completion, an average of 1 year.]

Критерии участия

Критерии включения

• Voluntary participation and written informed consent;
• 18-75 years older, no gender limitation;
• Eastern Cooperative Oncology Group (ECOG) score: 0-1;
• With a life expectancy ≥ 3 months;
• Pathologically diagnosed advanced solid tumor;
• Be able to provide fresh or archived tumour tissue;
• 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

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
• Previous or co-existing malignancies;
• Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
• Uncontrollable tumor-related pain;
• Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
• Received systemic antitumor therapy before the first dose;
• Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
• For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
• Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
• Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;
• A history of interstitial pneumonia/non-infectious pneumonia;
• Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
• Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
• With poorly controlled or severe cardiovascular disease;
• Active hepatitis B, hepatitis C;
• Patients with a history of immunodeficiency;
• Severe infection 30 days before the first dose.

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

• Sun Yat-Sen university cancer center — Гуанчжоу

Идентификаторы

NCT: NCT06703177 · SHR-1826-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗