Last update 27 Feb 2026

AMG-305

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
AMG 305, AMG305
Target
CD3 x CDH3 x MSLN
Action
stimulants, modulators
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), CDH3 modulators(Cadherin 3 modulators), MSLN modulators(Mesothelin modulators)
Therapeutic Areas
NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]
Active Indication
Advanced Lung Non-Small Cell CarcinomaBreast CancerColorectal Cancer+ [7]
Inactive Indication-
Originator Organization
Amgen, Inc.Amgen, Inc.
Active Organization
Amgen, Inc.Amgen, Inc.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Related

1
Clinical Trials associated with AMG-305
NCT05800964
/ CompletedPhase 1
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
100 Clinical Results associated with AMG-305
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100 Translational Medicine associated with AMG-305
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100 Patents (Medical) associated with AMG-305
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100 Deals associated with AMG-305
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell CarcinomaPhase 1
United States
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
Japan
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
Australia
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
Canada
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
France
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
Germany
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
South Korea
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
Spain
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
United Kingdom
Amgen, Inc.Amgen, Inc.
29 Sep 2023
Breast CancerPhase 1
United States
Amgen, Inc.Amgen, Inc.
29 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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