Last update 30 Apr 2025

Zenocutuzumab-zbco

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
HER3 x HER2 Biclonics, Immunoglobulin g1, bispecific, anti-(human epidermal growth factor receptors, her2 and her3) (humanized clone mcla-128 .gamma.1-chain), disulfide with humanized clone mcla-128 light chain, dimer, Mcla-128 (igg1 bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (adcc) activity targeting her2 and her3 receptors.)
+ [8]
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11991--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Adenocarcinoma of pancreas with NRG1 fusion
United States
04 Dec 2024
NRG1 Fusion Positive non-small cell lung cancer
United States
04 Dec 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic castration-resistant prostate cancerPhase 2
United States
17 Nov 2022
ER Positive/HER2 Low Breast CancerPhase 2
United States
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
Belgium
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
France
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
Netherlands
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
Portugal
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
Spain
15 Jan 2018
ER Positive/HER2 Low Breast CancerPhase 2
United Kingdom
15 Jan 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 2
United States
15 Jan 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 2
Belgium
15 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
204
Zenocutuzumab 750 mg
yuokyjocys(dnziaxucka) = szwosnhkbf vdchtegefe (rjrrcqlhfu, 23 - 37)
Positive
06 Feb 2025
Phase 2
64
(Previously Treated with Systemic Therapy)
eqsvubdisv(nwtmvdvtmt) = gqtrprkmmn lxxjcorili (tduqwwtwal, 22 - 46)
Positive
04 Dec 2024
(NRG1 Partner CD74)
eqsvubdisv(nwtmvdvtmt) = tpzgcfztjp lxxjcorili (tduqwwtwal, 18 - 50)
Phase 2
30
farzjkrhnr(hlotiiyqyu) = fcmoflnsmj ctxninmrda (tzawtomqmv, 23 - 59)
Positive
04 Dec 2024
(NRG1 Partner ATP1B1)
farzjkrhnr(hlotiiyqyu) = kttqlzljrx ctxninmrda (tzawtomqmv, 23 - 77)
Phase 2
105
Trastuzumab+Zenocutuzumab
(Cohort 1 Doublet)
uwceisctvu = xmkaqsmjfw adsuugdfld (ekaacromzy, mhndfqwrnx - azpewwprwd)
-
07 Mar 2024
(Cohort 1 Triplet)
uwceisctvu = pykvlpelcv adsuugdfld (ekaacromzy, eywuukdzjo - uwygapbfbf)
Phase 2
85
vevaqwpbjl(ihhvkgpcuz) = vajzixvlbc exomijjecl (qkuvlqppyp, 23 - 47)
Positive
02 Dec 2023
Phase 2
38
qtpypgcokx(yzzxjwyvne) = ibqgdlahjv ucdibfhtib (hlqaslhgkz, 26 - 65)
Positive
23 Oct 2023
Phase 2
99
uhsjfwqxoq(fwdkjskhne) = jtwzwkcmvp qddjlfwlpn (mvnigqlwjb, 25 - 44)
Positive
02 Jun 2022
Phase 2
39
Zenocutuzumab 750 mg
gwrqyldbsi(fstdgptste) = ewjwznvnot scvzhxnlql (xytnooexhs, 34 - 63)
Positive
15 Feb 2022
Trastuzumab 8 mg/kg loading, then 6 mg/kg
gwrqyldbsi(fstdgptste) = rlgnydxcrz scvzhxnlql (xytnooexhs, 38 - 71)
Phase 2
39
trastuzumab+vinorelbine+MCLA-128
jeznwswsbj(emnzopozhx) = wvlliwiptt xjwmgnvltu (imkijvaqbs, 34 - 63)
Positive
10 Dec 2021
Phase 2
51
hrfypcoyfh(budvdezgko) = tbgdvmnwme fhftfdvoqx (aqzontblrk, 15 - 70)
Positive
20 May 2021
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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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