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에이비온, ASCO서 'c-MET 저해제' 1상 디자인 발표 - 바이오스펙테이터

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에이비온, ASCO서 'c-MET 저해제' 1상 디자인 발표

입력 2021-06-08 10:37 수정 2021-06-08 11:25

바이오스펙테이터 윤소영 기자

[ASCO 2021]고형암 대상 'ABN401', 올해 2분기 내에 안전성 및 효능 발표 예정

에이비온(Abion)이 지난 4일부터 온라인으로 개최된 미국 임상종양학회(ASCO)에서 c-MET 저해제 ‘ABN401’의 임상 1상 디자인을 발표했다.

ABN401은 c-MET의 활성을 저해하는 저분자화합물이다. c-MET의 과활성화나 변이는 다양한 암을 생성하는데 관여한다고 알려져 있으며, ABN401은 이러한 c-MET을 타깃으로 한다. 에이비온은 현재 고형암 환자를 대상으로 ABN401의 안전성 및 내약성을 보기 위한 임상 1/2상을 국내와 호주에서 진행하고 있다(NCT04052971).

초록에 따르면 임상 1상은 고형암 환자를 대상으로 한 용량증량(dose-escalation) 시험, 2상은 c-MET 바이오마커를 나타내는 특정 적응증의 환자를 대상으로 한 용량확장(dose-expansion) 시험이다.

에이비온은 임상 1상을 통해 ABN401의 최대 내약용량(maximum tolerated dose, MTD)과 2상에서 사용될 용량(recommended Phase 2 dose, RP2D)을 알아볼 계획이다. 1상에 참여한 환자들은 7개의 코호트로 나뉘어 매일 ABN401(50mg, 100mg, 200mg, 400mg, 800mg, 1200mg, 1800mg)을 21일 주기로 경구 투약하게 된다. 동시에 10명의 c-MET 변이(MET 엑손14 스키핑/MET 증폭/c-MET 과발현) 비소세포폐암(NSCLC) 환자를 대상으로 중간용량인 ABN401 800mg에 대한 효능 확인을 위한 파일럿 확장(pilot expansion) 임상도 진행한다.

임상의 환자 모집은 2019년 8월 시작됐으며 현재 5번째 용량군의 시험까지 완료된 상태다. 6번째 용량의 환자모집은 올해 4월부터 시작됐다. 1상에서 RP2D가 정해지면 4가지 암종의 10~29명 환자를 대상으로 한 확장 임상이 시작될 예정이다. 또한 에이비온은 올해 2분기 내에 ABN401의 안전성과 효능에 대한 결과를 공개할 계획이다.

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