Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GYNBS
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| 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 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
AF-HPA
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Payload Info | ||||
| Therapeutic 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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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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| Gastric cancer |
1 Trials
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| Lung cancer |
1 Trials
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General Information of The Activity Data Related to This ADC
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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Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| 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 | ||
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| 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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References