Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0GYNBS)
| ADC Name |
XMT-1522
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| Synonyms |
XMT-1522; TAK-522
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| Organization |
Mersana Therapeutics (Originator);Takeda Pharmaceuticals (Top20 MNC) (No Rights)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
12
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| Antibody Name |
XMT-1519
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2)
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Antigen Info | ||||
| Payload Name |
AF-HPA
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Fleximer polymer
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Cell Line-derived Xenograft Model
| Standard Type | Value | Units | Cell Line | Disease Model |
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| Tumor Growth Inhibition value (TGI) |
≈ 100
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%
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JIMT-1 cells
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Breast ductal carcinoma
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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 | Disease control rate (DCR) |
83%
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| 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.
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| 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.
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| 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.
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| 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.
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Discovered Using Cell Line-derived Xenograft Model
| 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.
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| In Vivo Model | JIMT-1 CDX model | ||||
| In Vitro Model | Breast ductal carcinoma | JIMT-1 cells | CVCL_2077 | ||
References