A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Официальное название

A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Обзор

This is an open-label, multi-center phase II clinical study consisting of two parts: Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer. Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.

Вмешательства

• Препарат AK112
  Following a predefined dose and date.
• Препарат AK130
  Following a predefined dose and date.

Первичные конечные точки

• Number of subjects with adverse events (AEs) [Срок оценки: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.]
• Objective Response Rate (ORR) [Срок оценки: Through study completion, an average of 2 years]

Вторичные конечные точки (5)

• Disease control rate (DCR) [Срок оценки: Through study completion, an average of 2 years]
• Duration of Response (DoR) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
• Time to response (TTR) [Срок оценки: From date of randomization until the date of first documented response, assessed up to 24 months.]
• Progression Free Survival (PFS) [Срок оценки: Through study completion, an average of 2 years.]
• Overall survival (OS) [Срок оценки: Through study completion, an average of 2 years.]

Критерии участия

Критерии включения

• Be able and willing to provide written informed consent.
• Have a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
• According to RECIST v1.1, there is at least one measurable lesion.
• Has adequate organ function.
• All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment.
• Able to to comply with all requirements of study participation (including all study procedures).

Критерии исключения

• Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
• There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
• There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
• Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
• There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
• History of severe bleeding tendency or coagulation dysfunction.
• Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
• Pregnant or lactating female subject.

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

• Zhongshan Hospital Affiliated to Fudan University — Шанхай
• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07114315 · AK130-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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