A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Официальное название

An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Обзор

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Вмешательства

• Препарат SHR-A1811
  SHR-A1811.
• Препарат Carboplatin
  Carboplatin.
• Препарат Bevacizumab
  Bevacizumab.
• Препарат Oxaliplatin for Injection
  Oxaliplatin for injection.
• Препарат Paclitaxel injection
  Paclitaxel injection.
• Препарат Doxorubicin hydrochloride liposome injection
  Doxorubicin hydrochloride liposome injetction.
• Препарат Adebrelimab Injection
  Adebrelimab injection.

Первичные конечные точки

• Dose limited toxicity (DLT) [Срок оценки: Up to 21 days.]
• Recommended phase II dose (RP2D) [Срок оценки: Up to 21 days.]
• Objective response rate (ORR) [Срок оценки: Every 9 weeks lasting about one year.]

Вторичные конечные точки (7)

• Duration of response (DoR) [Срок оценки: Every 9 weeks lasting about one year.]
• Disease control rate (DCR) [Срок оценки: Every 9 weeks lasting about one year.]
• Progression free survival (PFS) [Срок оценки: Every 9 weeks lasting about one year.]
• Standard response rate (RR) [Срок оценки: Every 9 weeks lasting about one year.]
• Overall survival (OS) [Срок оценки: Approximately 3 years after the last subject enrolled.]
• Adverse events (AEs) [Срок оценки: From the first drug administration to within 90 days after the last dose.]
• Serious adverse events (SAEs) [Срок оценки: From the first drug administration to within 90 days after the last dose.]

Критерии участия

Критерии включения

• Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
• Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
• At least one measurable lesion conforming to RECIST v1.1.
• ECOG PS score: 0-1.
• Expected survival ≥ 12 weeks.
• Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Критерии исключения

• With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
• Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
• Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
• With hypertension and cannot be well controlled by antihypertensive drug treatment.
• Accompanied by poorly controlled or serious cardiovascular diseases.
• Subjects with serious infection within 1 month before the first medication.
• Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
• There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.

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

• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and T — Ухань

Идентификаторы

NCT: NCT06840002 · SHR-A1811-216-OC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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