Payload Information
General Information of This Payload
| Payload ID | PAY0GSHBE |
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| Name | Auristatin W derivative |
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| Synonyms |
Auristatin W derivative
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| Target | Microtubule (MT) | |||||
| Structure |
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
Lupartumab amadotin [Phase 1 (discontinued)]
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 | Phase 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
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| 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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