General Information of This Antibody
Antibody ID
ANI0UHCNZ
Antibody Name
Zanidatamab
Organization
Zymeworks BC, Inc.; BeiGene Ltd.
Indication
Ovarian cancer; Gastric cancer
Synonyms
ZW-25; ZW25; ZW 25
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Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized half-IgG1-kappa/(scFv-kappa-heavy)-h-CH2-CH3
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
 Antigen Info 
ChEMBI ID
CHEMBL4650256
DrugBank ID
DB15471
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Heavy Chain Sequence
GEVQLVESGGGLVQPGGSLRLSCAASGFTFADYTMDWVRQAPGKGLEWVGDVNPNSGGSI
YNQRFKGRFTFSVDRSKNTLYLQMNSLRAEDTAVYYCARNLGPSFYFDYWGQGTLVTVSS
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG
PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN
STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYVYPPSRDE
LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFALVSKLTVDKSRW
QQGNVFSCSVMHEALHNHYTQKSLSLSPG; GDIQMTQSPSSLSASVGDRVTITCRASQD
VNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQPEDFATYYC
QQHYTTPPTFGQGTKVEIKGGSGGGSGGGSGGGSGGGSGEVQLVESGGGLVQPGGSLRLS
CAASGFNIKDTYIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYL
QMNSLRAEDTAVYYCSRWGGDGFYAMDYWGQGTLVTVSSAAEPKSSDKTHTCPPCPAPEL
LGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREE
QYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYVLPPS
RDELTKNQVSLLCLVKGFYPSDIAVEWESNGQPENNYLTWPPVLDSDGSFFLYSKLTVDK
SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Varible Domain
GEVQLVESGGGLVQPGGSLRLSCAASGFTFADYTMDWVRQAPGKGLEWVGDVNPNSGGSI
YNQRFKGRFTFSVDRSKNTLYLQMNSLRAEDTAVYYCARNLGPSFYFDYWGQGTLVTVSS
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Heavy Chain Constant Domain 1
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV
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Heavy Chain Constant Domain 2
APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTK
PREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK
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Heavy Chain Constant Domain 3
GQPREPQVYVYPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS
DGSFALVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Hinge Region
EPKSCDKTHTCPPCP
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Heavy Chain CDR 1
GFTFADYT
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Heavy Chain CDR 2
VNPNSGGS
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Heavy Chain CDR 3
ARNLGPSFYFDY
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Light Chain Sequence
GDIQMTQSPSSLSASVGDRVTITCKASQDVSIGVAWYQQKPGKAPKLLIYSASYRYTGVP
SRFSGSGSGTDFTLTISSLQPEDFATYYCQQYYIYPATFGQGTKVEIKRTVAAPSVFIFP
PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL
TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
GDIQMTQSPSSLSASVGDRVTITCKASQDVSIGVAWYQQKPGKAPKLLIYSASYRYTGVP
SRFSGSGSGTDFTLTISSLQPEDFATYYCQQYYIYPATFGQGTKVEIK
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Light Chain Constant Domain
RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD
SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain CDR 1
QDVSIG
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Light Chain CDR 2
SAS
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Light Chain CDR 3
QQYYIYPAT
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Zanidatamab zovodotin [Phase 1 (discontinued)]
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
28%
Patients Enrolled
Eligible patients must have HER2-high advanced cancers (breast/GEA/others) progressing after standard therapies (trastuzumab-based regimens), measurable disease (expansion cohort), ECOG 0-1, adequate organ/cardiac function (LVEF ≥institutional normal).
Administration Dosage
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
Related Clinical Trial
NCT Number NCT03821233  Clinical Status PHASE1
Clinical Description
A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers
Primary Endpoint
Safety assessments include DLTs (4 weeks), AEs/lab abnormalities/ECG-LVEF changes/dose reductions (7 months) graded by CTCAE v5.0 for ZW49-treated patients.
Other Endpoint
Pharmacokinetics (serum concentrations), immunogenicity (ADAs), and efficacy outcomes (ORR/DCR/DOR/PFS per RECIST 1.1) are evaluated for up to 2 years in ZW49-treated cohorts.
Experiment 2 Reporting the Activity Date of This ADC [1]
Efficacy Data Disease control rate (DCR)
72%
Patients Enrolled
Eligible patients must have HER2-high advanced cancers (breast/GEA/others) progressing after standard therapies (trastuzumab-based regimens), measurable disease (expansion cohort), ECOG 0-1, adequate organ/cardiac function (LVEF ≥institutional normal).
Administration Dosage
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
Related Clinical Trial
NCT Number NCT03821233  Clinical Status PHASE1
Clinical Description
A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers
Primary Endpoint
Safety assessments include DLTs (4 weeks), AEs/lab abnormalities/ECG-LVEF changes/dose reductions (7 months) graded by CTCAE v5.0 for ZW49-treated patients.
Other Endpoint
Pharmacokinetics (serum concentrations), immunogenicity (ADAs), and efficacy outcomes (ORR/DCR/DOR/PFS per RECIST 1.1) are evaluated for up to 2 years in ZW49-treated cohorts.
References
Ref 1 A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers