Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FWYLZ
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| ADC Name |
Zanidatamab zovodotin
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| Synonyms |
zanidatamab zovodotin; ZW49
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| Organization |
Zymeworks (Originator);BeiGene (No Rights)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Zanidatamab
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
ZD02044
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-PEG3-Val-Cit
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
zovodotin
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Breast cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
28%
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| 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).
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| Administration Dosage |
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
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| 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.
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| 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.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
72%
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| 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).
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| Administration Dosage |
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
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| 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.
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| 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.
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