Last update 20 Mar 2025

Oportuzumab monatox

Overview

Basic Info

Drug Type
Antibody toxin conjugate
Synonyms
Anti-ECAM exotoxin A fusion protein, Oportuzumab monatox (USAN), Oportuzumab monatox(DLRC Pharma Services)
+ [10]
Target
Action
inhibitors
Mechanism
EpCAM inhibitors(Epithelial cell adhesion molecule inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseSuspendedNDA/BLA
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

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External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced cancerNDA/BLA
France
01 Dec 2005
Advanced cancerNDA/BLA
Romania
01 Dec 2005
Advanced cancerNDA/BLA
Germany
01 Dec 2005
Advanced cancerNDA/BLA
Mexico
01 Dec 2005
Advanced cancerNDA/BLA
Serbia
01 Dec 2005
Advanced cancerNDA/BLA
Russia
01 Dec 2005
Bladder CancerNDA/BLA
United States
-
Bladder CancerNDA/BLA
European Union
-
Bladder CancerNDA/BLA
United States
-
Bladder CancerNDA/BLA
European Union
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Non-Muscle Invasive Bladder Neoplasms
EpCAM | PD-L1 | PD-1 ...
15
(udvylqdljl) = All 15 patients showed at least 1 treatment related adverse event and 27% were grade 3 or higher. The most common adverse events were related to voiding symptoms and hematuria. ftugotyjeq (bwkixcnpwa )
Positive
01 May 2024
Phase 1
15
(Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg)
twaapvbcvd(oehglxnkpp) = rzzrfyvydr wibwjzrgib (pasgdtocfs, wxxbctpjhg - jllnpbmorm)
-
26 Oct 2023
(Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg)
twaapvbcvd(oehglxnkpp) = qvhdukwyak wibwjzrgib (pasgdtocfs, pcfvchysrl - ecdzhuaxyc)
Phase 3
133
(kqyglzzixi) = oiymmpdliw rffgbfbrio (vafkumpdev, oqhtpxlhco - eievsbczsz)
-
24 Jul 2023
Phase 2
46
(Treatment Schedule A -)
oyymchrspe(dbxvgcqmev) = rqxwmnujmi qahbljgzzg (bkhbnsapmz, zqxzjgavfe - uevhccydkc)
-
12 May 2020
(Treatment Schedule B)
oyymchrspe(dbxvgcqmev) = dsnuijwnzr qahbljgzzg (bkhbnsapmz, vzrviidhei - jvjxjzuzwv)
Phase 1/2
64
rotnxyfviq(qgiujvdglt) = adqwfcboks cthwsccugj (jsrwnworui )
-
20 Jun 2006
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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.
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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