Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0SWJIT
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| 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 | ||||
| Therapeutic 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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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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| Brain cancer |
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] | ||||
| 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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