YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer

Официальное название

A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer

Обзор

In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.

Вмешательства

• Препарат YL-13027
  YL-13027 is a small molecule inhibitor of the TGF-βRI target.
• Препарат HY-0102
  HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
• Препарат Gemcitabine
  Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
• Препарат Nab-paclitaxel
  Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Первичные конечные точки

• Objective response rate [Срок оценки: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.]
• Progression-free survival [Срок оценки: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.]

Вторичные конечные точки (3)

• Disease control rate [Срок оценки: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.]
• Adverse events [Срок оценки: From time of first dose to 30 days after the last dose.]
• Plasma concentration of YL-13027 and HY-0102 [Срок оценки: From one hour before the first dose to the last dose up to 24months.]

Критерии участия

Критерии включения

• Subject aged between 18 and 75 years.
• Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
• Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;
• Subjects have a good level of organ function.

Критерии исключения

• Subject suitable for potentially curative surgery.
• The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
• The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06662669 · YL-13027-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗