항체Curated CoreFDAApprovedApproved

tarlatamab (Imdelltra, AMG 757, tarlatamab-dlle)

Amgen

비교

분석

큐레이션 브리핑

한 줄로 읽는 이유

경쟁 포지션: Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine.

기전. Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity.

우선 정리한 핵심 프로그램입니다. 공개 출처가 있는 필드만 표시합니다.

구조화 데이터출처: ClinicalTrials.gov · PubMed · openFDACurated CoreFDA최근 동기화됨

구조화 데이터

개요

임상 2026년 9월 2일 (8일 전)PK/독성 2026년 9월 2일 (8일 전)

DLL3 × CD3

Extensive-stage small cell lung cancer after platinum-based chemotherapy

US, JP

Approved

imdelltra · tarlatamab · Imdelltra · AMG 757 · tarlatamab-dlle

2026-09-10

Data Confidence · High

Development Signal · Established

Technology

Half-life extended BiTE (bispecific T-cell engager)

Two single-chain variable fragments against DLL3 and CD3 fused to an Fc domain for extended half-life

DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target.

구조화 데이터

비교용 포지션

DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target.

Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion.

Half-life extended BiTE (bispecific T-cell engager)

DLL3 × CD3 · DLL3 expression by IHC is not required in the label but tracks with the biology.

CRS and neurologic toxicity management during step-up

Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine.

Target Product Profile (TPP)

ES-SCLC progressing on or after platinum-based chemotherapy

2L+

IV with step-up dosing and inpatient monitoring for early cycles

10 mg q2w after step-up

ORR ~40% at the 10 mg dose in DeLLphi-301

CRS and neurologic toxicity management during step-up

Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine.

Mechanism of Action

Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity.

Polyclonal T-cell activation with transient cytokine release during step-up dosing.

T-cell-mediated lysis of DLL3+ neuroendocrine tumor cells.

DLL3 expression by IHC is not required in the label but tracks with the biology.

Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion.

구조화 데이터

비임상 프로파일

xenograft model

Human, cynomolgus

~11 days (Fc-extended)

Cytokine kinetics, T-cell margination, radiographic response

Antibody PK/tox strategy

구조화 데이터

임상시험 & 결과

차트 로드 중…

임상 한눈에 보기

  • 39건의 ClinicalTrials.gov 임상 기록
  • Phase·Status 요약은 enrollment 상위 표본 기준입니다
  • 임상시험 탭에서 enrollment 상위 목록을 불러올 수 있습니다
  • Phase: Phase 1 · Phase 3 · Phase 2
  • Status: Approved for marketing · Recruiting · Active, not recruiting
  • 주요 endpoint: Phase 1a: Number of participants with Adverse Events (AEs) · Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs) · Phase 1a: Number of participants with AEs · serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity · Phase 1a: Number of participants with AEs leading to dose modifications
  • 선택한 코호트 보고값: ORR 57.1%
  • PFS: 6.5
  • 핵심: The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatama…

임상시험이 많습니다. 임상시험 탭에서 Phase/Status 필터·검색을 사용하세요.

수집된 임상 필드(phase, status, endpoint 등) 기반 자동 요약입니다. 효능 수치는 선택한 등록 결과이며 전적응증 값이 아닙니다.

개발 타임라인

  1. FDA accelerated approval (2L ES-SCLC)

    APPROVAL · 2024년 5월

출처 및 참고문헌

바이오정보모아는 연구·교육용 과학·의약품 개발 정보입니다. 진료, 진단, 치료 지침, 규제 자문이 아닙니다.

자주 묻는 질문

Imdelltra (tarlatamab)은 어떤 치료제인가요?
Imdelltra (tarlatamab)(Amgen)은 DLL3 × CD3 표적 항체로, Extensive-stage small cell lung cancer after platinum-based chemotherapy 영역에서 개발·상용화 중입니다. 데이터는 바이오정보모아 (BioJungboMoa)에서 ClinicalTrials.gov·openFDA·PubMed 기반으로 정리합니다.
Imdelltra (tarlatamab)의 임상 단계는?
Imdelltra (tarlatamab)은 FDA 승인 또는 승인 단계로 표시되어 있습니다.
비슷한 프로그램과 어떻게 비교하나요?
바이오정보모아 (BioJungboMoa) 비교 페이지에서 PK/PD, 독성, 임상 효능 지표를 나란히 볼 수 있습니다. 동일 타깃·모달리티 프리셋을 함께 참고하세요.