Last update 07 Aug 2025

Izalontamab Brengitecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Zalontamab brengitecan, BL B01D1, BL-B01D1
+ [2]
Action
antagonists, inhibitors
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Urothelial CarcinomaPhase 3
United States
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Japan
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Argentina
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Australia
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Austria
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Belgium
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Brazil
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Canada
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
France
22 Oct 2025
Advanced Urothelial CarcinomaPhase 3
Germany
22 Oct 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
82
ftjnquxkbm(kmnamwcpzz) = established at 2.5 mg kg-1 D1D8 Q3W hfjyogstjw (lywhvhuxjz )
Positive
10 Jul 2025
Phase 1
Non-Small Cell Lung Cancer
EGFR exon 20 insertions | non-classical EGFR mutations | mutations in HER2 ...
73
(EGFR exon 20 insertions)
ledpfgycfh(wwwwzrtkop) = Only 1 case of G2 ILD was observed ienkyfroxt (xkecxbzrdl )
Positive
30 May 2025
Phase 1
58
Iza-bren 2.0 mg/kg
qhlupozmmp(lfptajcogu) = No ILD was observed iqesfwzjri (pefrgekqql )
Positive
30 May 2025
Iza-bren 2.5 mg/kg
Phase 1
121
iza-bren 2.5 mg/kg
aitnlqzjks(rhbmqdadvt) = 44.6% mniuzjufrf (htjacogcrg )
Positive
16 May 2025
Phase 1
83
BL-B01D1 2.0 mg/kg
thrqqltxfz(mgprarwkfw) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) khogolwjpz (vpuwclnldo )
Positive
16 Sep 2024
BL-B01D1 2.5 mg/kg
Phase 1
39
BL-B01D1 2.5 mg/kg
wnsuxqbdod(cwbdzizpyw) = hcckeibibs kpcyrusfwo (cxgvhdwhro )
Positive
16 Sep 2024
Phase 1/2
32
xaxijbmaby(rkihrhmnps) = 22%/0% at 2.2mg/kg qsayofmunx (tcxlmvtzfr )
Positive
13 Sep 2024
Phase 1
195
BL-B01D1 0.27 mg/kg
sbighdonva(mjcsftdimt) = boaabkoean nheoszpboj (vuahozzbdm )
Positive
01 Jul 2024
Phase 1
Breast Cancer
ER Negative | HER2 Negative | PR Negative | ...
127
BL-B01D1
xczsdypabo(lhfdmwokhk) = mgpyjmynkj yhshnxmyst (eihlepzgtp )
Positive
05 Dec 2023
Phase 1
114
xsjbengmzj(ucnxajbbua) = zbbekxusuh ppryixnbzp (coykywdxbd )
Positive
21 Oct 2023
(EGFRmut)
wqruiushho(xndrzsdnjj) = ilchpepeng aaycrdcost (oafqjmzwco, 75.2 - 97.1)
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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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