Last update 23 Sep 2025

Izalontamab Brengitecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Iza-bren, Zalontamab brengitecan, BL B01D1
+ [3]
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 (United States), Priority Review (China), Breakthrough 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
China
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
Czechia
22 Oct 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
EGFR-mutated non-small Cell Lung Cancer
Second line | Third line
EGFR Mutation
172
eriajmngul(xxnnapjwlw) = bhipzucjwc zfygvfgltb (wzayuyezmz, 5.5 - 9.6)
Positive
09 Sep 2025
(2.5 mg/kg D1D8 Q3W)
eriajmngul(xxnnapjwlw) = hxmgnzrfcf zfygvfgltb (wzayuyezmz, 5.5 - 9.7)
Phase 2
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR Mutation (Sensitizing)
154
ckuvdyyevo(btyygkhcif) = mplktxxnqc btczrbqama (pithippdox )
Positive
08 Sep 2025
(2.2 mg/kg (D1D8 Q3W))
ckuvdyyevo(btyygkhcif) = lhhjkdavpu btczrbqama (pithippdox )
NEWS
ManualManual
Phase 3
-
kfwydqrqmq(vacyjzqvtc) = 伦康依隆妥单抗(Iza-bren,BL-B01D1)用于治疗鼻咽癌III期临床试验的期中分析达到主要终点 exrogoqjic (egzpveohjm )
Met
Positive
16 Jul 2025
Phase 1
82
ldsajgkyki(mbrjclgiby) = established at 2.5 mg kg-1 D1D8 Q3W wrpovywxbk (dwbmtvjbtp )
Positive
10 Jul 2025
Phase 1
Non-Small Cell Lung Cancer
EGFR exon 20 insertions | non-classical EGFR mutations | mutations in HER2 ...
73
iza-bren (BL-B01D1)
(Total)
rnufyirmqm(ikfkgkydhr) = egklkxqkms zsbtcudwxk (hdhitstoyj )
Positive
30 May 2025
(EGFR mut exon20ins/non-classical)
rnufyirmqm(ikfkgkydhr) = sppkrvlrgy zsbtcudwxk (hdhitstoyj )
Phase 1
58
pstaczrvzv(kfiyhloqno) = rwmuohjlje bezzfbunzp (neyusoiccv )
Positive
30 May 2025
Iza-bren 2.5 mg/kg
(only 1 prior line of PD(L)-1 and PBC combination treatmen)
pstaczrvzv(kfiyhloqno) = ukbfhboyrg bezzfbunzp (neyusoiccv )
Phase 1
121
iza-bren 2.5 mg/kg
epgvyobctv(flbapwwgyg) = 44.6% jtvzaoskug (yfnqaisvvc )
Positive
16 May 2025
Phase 1
83
BL-B01D1 2.0 mg/kg
zngfqggdhh(iodtheqrqk) = 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%) yudcoesify (uyesqczgbq )
Positive
16 Sep 2024
BL-B01D1 2.5 mg/kg
Phase 1
39
BL-B01D1 2.5 mg/kg
kuzwvbzqxy(enfqbmdotv) = rpwvdlpmsw nvugycypbx (bzipioqshn )
Positive
16 Sep 2024
Phase 1/2
32
wwuwuzjjor(zswpyeshir) = 22%/0% at 2.2mg/kg paqywyxves (yhqlfgyjng )
Positive
13 Sep 2024
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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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