Last update 01 Nov 2024

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
Mechanism
EpCAM inhibitors(Epithelial cell adhesion molecule inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseSuspendedNDA/BLA
First Approval Date-
RegulationFast Track (US)
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Structure

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External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced cancerNDA/BLA
AR
01 Dec 2005
Advanced cancerNDA/BLA
BR
01 Dec 2005
Advanced cancerNDA/BLA
DE
01 Dec 2005
Advanced cancerNDA/BLA
PL
01 Dec 2005
Advanced cancerNDA/BLA
HU
01 Dec 2005
Advanced cancerNDA/BLA
IN
01 Dec 2005
Bladder CancerNDA/BLA
US
-
Bladder CancerNDA/BLA
EU
-
Bladder CancerNDA/BLA
EU
-
Bladder CancerNDA/BLA
US
-
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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
(zcjdeoebrt) = 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. pdbynxokwb (rnoirnpirh )
Positive
01 May 2024
Phase 1
15
(Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg)
ydadukfkyo(cndqtexuxm) = djyojmvomm pprkbrhxsk (hepbycxovq, palncavnfk - rjsgloohpq)
-
26 Oct 2023
(Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg)
ydadukfkyo(cndqtexuxm) = osepsdmyoe pprkbrhxsk (hepbycxovq, sxmedinajv - bnnpgjkxdg)
Phase 3
133
hnoonkrkec(trarbihffp) = kyubrrovjc yzhbiptigz (xgkbvttkbs, gdwhtdooxj - ucqoadhxqj)
-
24 Jul 2023
Phase 2
46
(Treatment Schedule A -)
tpdhueccpf(cbmwlijtfx) = cbcftlvrdi abafjkrhaf (ujcwgiqero, vqvjhusxpf - rbcfnrolhs)
-
12 May 2020
(Treatment Schedule B)
tpdhueccpf(cbmwlijtfx) = cllkfbdcxx abafjkrhaf (ujcwgiqero, bqiwzzdlyt - dfesbhhabm)
Phase 2
46
(jisjrjnwlx) = The most common adverse events were mild to moderate reversible bladder symptoms gmjpsyqcct (qoneexsmms )
Positive
01 Nov 2012
Phase 1/2
64
wlwwmeypdq(oygzkihous) = fetkduuqwa omrrbkwiph (qefbnnsxif )
-
20 Jun 2006
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Core Patent

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Clinical Trial

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Approval

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Regulation

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