Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0PXYTA
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|---|---|---|---|---|---|---|
| ADC Name |
MEDI4276
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| Synonyms |
MEDI4276
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| Organization |
AstraZeneca (Top20 MNC) (Originator)
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| Drug Status |
Phase 1/2 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
MEDI-4276
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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 |
AZ13599185
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Maleimido-caproyl based linker
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Linker Info | ||||
| Conjugate Type |
Reactive 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 | ||
|---|---|---|---|---|---|---|---|---|---|
| Breast cancer |
1 Trials
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| Gastric cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 610 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 490 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 568 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg, N = 3, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 1790 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1610 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1950 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 3310 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 3720 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4710 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 4490 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5180 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7550 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 6680 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 8200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 13000 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 7810 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 12300 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 10900 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 14800 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 20100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 14200 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 30400 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 36100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-inf
|
[1] |
| Maximum Observed Concentration (Cmax) | 21400 | ng/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42600 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-inf
|
[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 490 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 568 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1610 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1950 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 3720 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4710 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5180 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7550 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 8200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 13000 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 12300 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 14800 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 20100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 30400 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 36100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42600 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-inf
|
[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 490 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 568 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1610 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1950 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 3720 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4710 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5180 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7550 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 8200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 13000 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 12300 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 14800 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 20100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 30400 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 36100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-inf
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42600 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-inf
|
[1] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 0.509 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 490 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 568 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 90.8 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.05 mg/kg,N = 3
|
[1] |
| Elimination Half-Life (t1/2) | 0.631 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1610 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1950 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 61.5 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.1 mg/kg, N = 3
|
[1] |
| Elimination Half-Life (t1/2) | 0.829 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 3720 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4710 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 50 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.2 mg/kg, N = 3
|
[1] |
| Elimination Half-Life (t1/2) | 1.19 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5180 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7550 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 41.8 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.3 mg/kg, N = 3
|
[1] |
| Elimination Half-Life (t1/2) | 1.4 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 8200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 13000 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6, AUC0-inf
|
[1] |
| Clearance (CL) | 31.3 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.4 mg/kg, N = 6
|
[1] |
| Elimination Half-Life (t1/2) | 1.37 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 12300 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 28.6 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.5 mg/kg, N = 3
|
[1] |
| Elimination Half-Life (t1/2) | 1.43 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 14800 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 20100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10, AUC0-inf
|
[1] |
| Clearance (CL) | 33.5 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.6 mg/kg, N = 10
|
[1] |
| Elimination Half-Life (t1/2) | 1.67 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 30400 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 36100 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12, AUC0-inf
|
[1] |
| Clearance (CL) | 22.4 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.75 mg/kg, N = 12
|
[1] |
| Elimination Half-Life (t1/2) | 1.9 | day |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-last
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42600 | ng*day/mL |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3, AUC0-inf
|
[1] |
| Clearance (CL) | 22.5 | mL/day/kg |
Pharmacokinetic Parameters of MEDI4276 after the First Dose, 0.9 mg/kg, N = 3
|
[1] |
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 | [2] | ||||
| Patients Enrolled |
Eligibility requires HER2+ advanced breast/gastric cancer patients (age≥18) with prior HER2-targeted therapy and measurable disease (RECIST 1.1), excluding recent anticancer treatment (<28 days), excessive anthracycline exposure, or active brain metastases.
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| Administration Dosage |
Participants received IV dose of 0.05 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
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| Related Clinical Trial | |||||
| NCT Number | NCT02576548 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1/2 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include safety assessment (AEs/SAEs/DLTs) to determine MTD, with monitoring through 90 days post-MEDI4276 dose, covering lab tests, vital signs, and ECGs for comprehensive safety profile evaluation.
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| Other Endpoint |
Secondary objectives evaluate efficacy (ORR/PFS/OS over 3 years) and PK/immunogenicity (Cmax/AUC/ADA incidence within 30 days post-treatment), measuring tumor response and drug exposure while tracking antibody development.
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References
