A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

Официальное название

A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors

Обзор

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Вмешательства

• Препарат SHR-9839 for Injection
  SHR-9839 for injection.
• Препарат SHR-A1921 for Injection
  SHR-A1921 for injection.
• Препарат SHR-A2009 for Injection
  SHR-A2009 for injection.
• Препарат Almonertinib Mesilate Tablets
  Almonertinib Mesilate Tablets.
• Препарат Pemetrexed Disodium for Injection
  Pemetrexed Disodium for Injection.
• Препарат Carboplatin for injection
  Carboplatin for injection.
• Препарат Paclitaxel injection
  Paclitaxel injection.
• Препарат SHR-1316 Injection
  SHR-1316 injection.
• Препарат SHR-9839 for Injection (sc)
  SHR-9839 for Injection (sc).

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLT) (phase IB) [Срок оценки: 21 days after the first dose was administered to each subject, up to approximately 24 months.]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB) [Срок оценки: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.]
• Objective Response Rate (ORR) (phase II). [Срок оценки: The first treatment lasted until disease progression, up to approximately 24 months.]

Вторичные конечные точки (1)

• Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II) [Срок оценки: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.]

Критерии участия

Критерии включения

• Aged 18-75 years old (inclusive), regardless of gender.
• Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
• At least one measurable tumor lesion according to RECIST v1.1.
• ECOG performance score of 0-1.
• Life expectancy ≥ 12 weeks.
• Adequate bone marrow and organ function.
• Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.

Критерии исключения

• Patients with active central nervous system ( CNS ) metastases.
• Spinal cord compression not be cured by surgery or radiotherapy.
• Subjects with uncontrollable tumor-related pain.
• Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
• Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
• Received > 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
• Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
• Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
• History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
• Serious cardiovascular and cerebrovascular diseases.
• Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
• History of immunodeficiency, including HIV test positive.
• Active hepatitis B or hepatitis C infection.
• History of severe allergic reactions to any component of any study drug to be accepted.
• Known history of alcohol or drug dependence.
• Mental disorders or poor compliance.
• Pregnant or lactating women.
• Patients with any active, known or suspected autoimmune disease.
• Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.
• Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Henan Cancer Hospital — Чжэнчжоу
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT06474455 · SHR-9839-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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