Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0SWJIT)
| ADC Name |
AMG 595
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| Synonyms |
AMG 595
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| Organization |
ImmunoGen (Top20 MNC) (Originator);Amgen (Top20 MNC)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3.5
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| Structure |
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| Antibody Name |
Anti-EGFRvIII mAb
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Antibody Info | ||||
| Antigen Name |
Epidermal growth factor receptor variant III (EGFRvIII)
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Antigen Info | ||||
| Payload Name |
DM1
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
emtansine
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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
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 | stable disease (SD) |
47%
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| Patients Enrolled |
Eligible subjects must have recurrent WHO Grade IV GBM (Parts 1-2) or Grade III AA (Part 1 only) with EGFRvIII+ expression (IHC-confirmed), Karnofsky score ≥70%, measurable disease (Macdonald criteria), and adequate organ function (ANC ≥1.5x10<sup>9</sup>/L, QTcF ≤470ms, eGFR >45 mL/min). Exclusions involve recent CNS hemorrhage (>Grade 1), significant neuropathy/ECG abnormalities, active infections, recent radiotherapy (≤12 weeks), or antiangiogenic therapy (bevacizumab within 4 weeks for Part 1; any prior use for Part 2).
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| Administration Dosage |
In this phase 1, first-in-human, open-label, sequential-dose, exploration study, adults with recurrent GBM received AMG 595 once every 3 weeks (Q3W) according to incremental dosing cohorts (0.5-3.0 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT01475006 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII) | ||||
| Primary Endpoint |
The primary safety assessment includes ≥Grade 3 CTCAE-defined adverse events in lab tests, physical exams, ECGs, or vital signs evaluated 28 days post-enrollment for each cohort. PK parameters (Cmax, Cmin, t½) are analyzed across 8 timepoints over 6 weeks. Objective tumor response in GBM is assessed per Macdonald criteria over 3 years, while DLT evaluation determines the MTD at defined intervals.
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| Other Endpoint |
Secondary efficacy measures include clinical benefit rate assessed every 6 months, progression-free survival, and overall survival tracked over 3 years. Immunogenicity (anti-AMG 595 antibodies) is monitored throughout the study period.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Partial Response (PR) |
6%
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| Patients Enrolled |
Eligible subjects must have recurrent WHO Grade IV GBM (Parts 1-2) or Grade III AA (Part 1 only) with EGFRvIII+ expression (IHC-confirmed), Karnofsky score ≥70%, measurable disease (Macdonald criteria), and adequate organ function (ANC ≥1.5x10<sup>9</sup>/L, QTcF ≤470ms, eGFR >45 mL/min). Exclusions involve recent CNS hemorrhage (>Grade 1), significant neuropathy/ECG abnormalities, active infections, recent radiotherapy (≤12 weeks), or antiangiogenic therapy (bevacizumab within 4 weeks for Part 1; any prior use for Part 2).
Click to Show/Hide
|
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| Administration Dosage |
In this phase 1, first-in-human, open-label, sequential-dose, exploration study, adults with recurrent GBM received AMG 595 once every 3 weeks (Q3W) according to incremental dosing cohorts (0.5-3.0 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT01475006 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII) | ||||
| Primary Endpoint |
The primary safety assessment includes ≥Grade 3 CTCAE-defined adverse events in lab tests, physical exams, ECGs, or vital signs evaluated 28 days post-enrollment for each cohort. PK parameters (Cmax, Cmin, t½) are analyzed across 8 timepoints over 6 weeks. Objective tumor response in GBM is assessed per Macdonald criteria over 3 years, while DLT evaluation determines the MTD at defined intervals.
Click to Show/Hide
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| Other Endpoint |
Secondary efficacy measures include clinical benefit rate assessed every 6 months, progression-free survival, and overall survival tracked over 3 years. Immunogenicity (anti-AMG 595 antibodies) is monitored throughout the study period.
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