ASCO: 智擎 NBTXR3,PEP503肝癌phase I/II期中: 7例可評估(3例完全反應/3例部分反應/1例疾病穩定)

智擎授權夥伴肝癌藥臨床試驗 獲正面數據 2018-01-24 21:50經濟日報 記者黃文奇╱即時報導 智擎（4162）24日宣布，該公司合作夥伴 Nanobiotix 在美國臨床腫瘤協會胃腸道癌症年會發表PEP503 肝癌第一／二期臨床試驗期中正向數據顯示優異的安全性及明顯的抗腫瘤效果。智擎授權夥伴法國 Nanobiotix 公司（Euronext: NANO）於本月19日在美國舊金山舉辦之美國臨床腫瘤協會胃腸道癌症年會（ASCO），發表 NBTXR3（PEP503）於肝癌第一期臨床試驗期中結果及令人振奮的數據資料。智擎去年前三季稅後虧損1.64億元，每股淨損1.12元。智擎表示，該試驗過程中沒有發生任何與產品有關的不良事件，且在七位可評估病患中，有三位達到腫瘤完全反應，腫瘤完全消失。在試驗設計與結果本試驗針對肝细胞癌或轉移性肝癌患者，以NBTXR3 進行腫瘤內或動脈注射後，再進行高精密的全身立體定位放射線治，預計將病患分成四組，分別注射相較於腫瘤體積為 10%、15%、22%與 33%之NBTXR3 劑量，目前已完成 10%與 15%劑量的病患收案。智擎說，本試驗於過程中沒有發生與產品有關的不良事件以及劑量限制性毒性，顯示NBTXR3具優異的安全性。此外，參與本試驗之所有病患皆成功完成NBTXR3的注射，且NBTXR3 於腫瘤內的分布情形良好，並無明顯位移的情形發生；同時並發現 NBTXR3 不會影響影像導引放射治療的可靠性。另外，臨床試驗的期中數據顯示，在七例可評估病患中，其中有三例達到腫瘤完全反應，三例達到腫瘤部分反應，腫瘤直徑比治療前縮小達 30%以上，一例則呈現疾病穩定；腫瘤直徑比治療前增大不足 20%，縮小不足 30%，腫瘤反應率高達 86%，顯示 NBTXR3 合併放射線治療具有明顯的抗腫瘤效果。

Official Title: A Phase I-II Study of NBTXR3 Activated by Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Cancers

Estimated Enrollment: 200 participants/ Intervention Model: Single Group Assignment/ Masking: None (Open Label)/ Primary Purpose: Treatment/ Study Start Date : November 2015/ Estimated Primary Completion Date : June 2017

Estimated Study Completion Date : December 2018  

Brief Summary: The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers. Detailed Description: This is a prospective, open-label, non-comparative and non-randomized study, to be conducted in 2 phases: a dose-escalation phase, to determine the recommended dose of NBTXR3 and to evaluate its safety/tolerability and preliminary clinical activity; and a dose-expansion phase, which will be a cohort expansion at the recommended dose of NBTXR3. Patients will receive a single administration of NBTXR3 on day of injection, as a super selective transcatheter arterial or intrahepatic lesion injection activated by Stereotactic Body Radiation Therapy starting 24 hours post injection. The total radiotherapy dose will be maximum 45 Gy, delivered as three fractions of 15 Gy each max, over 5 to 7 days (45 Gy, 3x15 Gy, over 5 to 7 days).the visit of End of Treatment (EOT) will take place 12 to 13 weeks after the administration of the last radiotherapy fraction and includes the evaluation of global clinical, radiological and laboratory parameters.