產品 ELI-002 介紹

ELI-002 是一種結構新穎的 AMP 治療性疫苗,針對 KRAS 驅使的癌症。KRAS 突變是人類癌症中最普遍 的突

變之一。ELI-002 由 AMP 修飾的突變 KRAS 肽抗原和 ELI-004(一種 AMP 修飾的免疫刺激性寡核苷酸佐劑)組

成。

ELI-002 is a structurally novel AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among

the most prevalent in human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and

ELI-004, an AMP modified immune-stimulatory oligonucleotide adjuvant.

胰臟癌(Pancreatic)介紹
Pancreatic cancer is a type of cancer that starts in the pancreas.
胰腺癌是一種始於胰腺的癌症。

Pancreatic adenocarcinoma is the most common type of pancreatic cancer, it is about 85%.So,the term pancreatic

cancer is sometimes used to refer directly to pancreatic adenocarcinoma.

胰臟腺癌是最常見的胰腺癌類型 ，佔了 85%。因此胰臟癌一詞有時也用來直接指稱胰臟腺癌。

胰臟癌(Pancreatic)常見症狀
Yellowing of the whites of the eyes or skin (jaundice), itchy skin, darkening of the small and lightening of the

large, loss of appetite or weight loss, feeling tired or low energy, high temperature, or feeling hot or shaking.

Pain in the upper abdomen and back, worse when eating or lying down, and better when leaning forward

Symptoms of indigestion, such as bloating.

眼白或皮膚變黃（黃疸）
，皮膚發癢、小號顏色變深和大號顏色變淺、食慾不振或體重減輕、感到疲倦或

沒有精力、高溫，或感覺熱或發抖。腹部上部和背部疼痛，吃飯或躺下時感覺更糟，身體前傾時感覺更好

消化不良的症狀，例如腹脹

ELI-002 對於胰臟癌(Pancreatic)的治療效果
治療原理 Principles of treatment
ELI-002 是一種結構新穎的 AMP 治療性疫苗，針對 KRAS 驅使的癌症。 KRAS 突變是人類癌症中最普遍
的突變之一。 ELI-002 由 AMP 修飾的突變 KRAS 肽抗原和 ELI-004（一種 AMP 修飾的免疫刺激性寡核

苷酸佐劑）組成。

ELI-002 is a structurally novel AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among

the most prevalent in human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and
ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant.
主要觀察指標 Primary Outcome Measures
1.

Determine the MTD of ELI-002 and the RP2D [ Time Frame: 28 days after first dose ]

The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.
確定 ELI-002 和 RP2D 的 MTD(最大耐受劑量) [ 時間範圍：第一次給葯后 28 天 ]

MTD 調到最高劑量水準，其中<33%的受試者仍有殘留毒性。

2.

Evaluate the safety of ELI-002 [ Time Frame: 30 days after last dose ]
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital
signs.
評估 ELI-002 的安全性 [ 時間範圍：最後一次給葯后 30 天 ]

安全性將通過不良事件的發生率以及臨床上的觀察和生命體徵來評估。