Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0WCYUM
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| ADC Name |
Lupartumab amadotin
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| Synonyms |
lupartumab amadotin; BAY1129980; BAY 1129980
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| Organization |
Bayer (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Lupartumab
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Antibody Info | ||||
| Antigen Name |
Ly6/PLAUR domain-containing protein 3 (LYPD3)
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Antigen Info | ||||
| Payload Name |
Auristatin W derivative
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-hydrazide linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
amadotin
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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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| Colorectal cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Prostate cancer |
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] | ||||
| Patients Enrolled |
Inclusion requires age ≥18, ECOG 0-1, life expectancy ≥12 weeks, measurable advanced solid tumors (C4.4a+), and adequate organ function. Exclusion covers recent anticancer therapy (<4 weeks), active skin toxicity, psoriasis, unhealed wounds, serious cardiac/liver disease, CNS metastasis (unless stable >3 months), HIV/HBV/HCV, CKD (GFR <50), recent major surgery, pregnancy, or other high-risk conditions affecting compliance.
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| Administration Dosage |
Starting dose is 0.15mg/kg intravenous (I.V.) administration every 21 days.
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| Related Clinical Trial | |||||
| NCT Number | NCT02134197 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Pharmacodynamics of the Anti-C4.4a Antibody Drug Conjugate BAY1129980 in Subjects With Advanced Solid Tumors Known to Express C4.4a | ||||
| Primary Endpoint |
The study determines the maximum tolerated dose (MTD) of BAY1129980, defined as the highest dose with <20% DLT incidence during Cycle 1 or the maximum administered dose. Safety is assessed via adverse events (AE) monitoring over 2 years.
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| Other Endpoint |
Key evaluations include baseline C4.4a tumor expression via IHC, RECIST 1.1-assessed tumor response, BAY1129980 plasma concentration (AUC 0-tlast), and antidrug antibody titers over 2 years.
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