Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Other Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom

Официальное название

An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination With Adebrelimab and Other Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma

Обзор

This study evaluated the safety and efficacy of SHR-8068 in combination with Adebrelimab and other anti-tumor drugs in the treatment of advanced renal cell carcinoma

Вмешательства

• Препарат SHR-8068；Adebrelimab ；Bevacizumab
  SHR-8068+ Adebrelimab + Bevacizumab
• Препарат SHR-8068；Adebrelimab ；HS-10516
  SHR-8068+ Adebrelimab +HS-10516
• Препарат SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516
  SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: 21days after the first administration of each subject]
• Overall response rate(ORR) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]

Вторичные конечные точки (4)

• Progression-free survival (PFS) by investigator [Срок оценки: Until progression or death, assessed up to approximately 3 year]
• Duration of response (DOR) by investigator assessment [Срок оценки: Until progression or death, assessed up to approximately 3 year]
• Disease control rate (DCR) by investigator assessment [Срок оценки: Until progression, assessed up to approximately 3 year]
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Срок оценки: until to 90 days after the last dose，assessed up to approximately 3 years]

Критерии участия

Критерии включения

• Age 18 to 75 years old (including boundary values)
• Volunteer to participate in this clinical study and sign informed consent;
• ECOG score 0-1;
• Expected survival ≥3 months;
• Patients with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology;
• Tumor tissue samples must be provided for testing
• There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
• Adequate bone marrow and organ function.

Критерии исключения

• Have previously used or are currently using HIF inhibitors.
• Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
• Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
• Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.
• There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
• Suffering from other active malignant tumors within 3 years or at the same time.
• Patients who have received organ transplants in the past (excluding corneal transplants).
• A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.
• There are clinical symptoms or diseases of the heart that are not well controlled.
• Active tuberculosis.
• Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
• The toxicity and/or complications of previous intervention measures have not been restored to the level of NCI-CTCAE≤1 or the inclusion and exclusion criteria.
• Subjects with active hepatitis B or active hepatitis C.
• As determined by the researcher, there are other factors that may affect the research results or lead to the forced termination of this study midway

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07239596 · SHR-8068-207-RCC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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