General Information of This Antibody
Antibody ID
ANI0YTLOU
Antibody Name
XMT-1519
Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG1-kappa
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
 Antigen Info 
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYSMNWVRQAPGKGLEWVSYISSSSSTIYY
ADSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARGGHGYFDLWGRGTLVTVSSAST
KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY
SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV
FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY
RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTK
NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG
NVFSCSVMHEALHNHYTQKSLSLSPG
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Light Chain Sequence
EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIP
DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYHHSPLTFGGGTKVEIKRTVAAPSVFIFP
PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL
TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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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
XMT-1522 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Disease control rate (DCR)
83%
Patients Enrolled
Eligible patients have HER2+ breast, gastric, or NSCLC (IHC 2+/3+), ECOG 0-1, adequate organ function, and progression after standard therapies. Exclusions include active infections, significant cardiac disease, recent anticancer therapy (<28 days), brain metastases, prior cardiotoxic anthracyclines, or additional malignancies within 5 years.
Administration Dosage
XMT-1522 treatment will administered in groups of patients who will receive doses that increase over time. Once the maximum tolerated dose or recommended Phase 2 dose is achieved, new groups of patients will receive XMT-1522 at this fixed dose.
Related Clinical Trial
NCT Number NCT02952729  Clinical Status PHASE1
Clinical Description
A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1522 in Patients With Advanced Breast Cancer and Other Advanced Tumors Expressing HER2
Primary Endpoint
The study evaluates the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of XMT-1522 over 14 weeks through monitoring adverse events, dose-limiting toxicities (DLTs), and concomitant medication use.
Other Endpoint
Pharmacokinetic parameters (Tmax, Cmax, AUC) of XMT-1522 are measured frequently after dosing. Tumor response is assessed via RECIST every 6 weeks up to 12 months, while immunogenicity (anti-drug antibodies) is monitored periodically over ~100 days.
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 100% Positive HER2 expression (HER2+++/++)
Method Description
XMT-1522 (3 mg/kg, every seven days x3) induces efficient tumor cell killing in cell line-derived models of JIMT-1 cells with HER2 expression with high expression.
In Vivo Model JIMT-1 CDX model
In Vitro Model Breast ductal carcinoma JIMT-1 cells CVCL_2077
References
Ref 1 Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
Ref 2 A Novel Anti-HER2 Antibody-Drug Conjugate XMT-1522 for HER2-Positive Breast and Gastric Cancers Resistant to Trastuzumab Emtansine. Mol Cancer Ther. 2019 Oct;18(10):1721-1730. doi: 10.1158/1535-7163.MCT-19-0207. Epub 2019 Jul 10.