Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0SZKXH
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|---|---|---|---|---|---|---|
| ADC Name |
BYON3521
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| Synonyms |
BYON3521
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| Organization |
Byondis (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
1.8
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| Structure |
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| Antibody Name |
SYD2884
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET); Macrophage-stimulating protein receptor (MST1R)
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Antigen Info | ||||
| Payload Name |
Seco-DUBA
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Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
Mal-PEG2-Val-Cit-PABA-Cyclization Spacer
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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| Combination Type |
duocarmazine
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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 | ||
|---|---|---|---|---|---|---|---|---|---|
| Cervical cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Melanoma |
1 Trials
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| Ovarian cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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ADC-specific functional property(2027 Update)
Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
|---|---|---|
| yes |
The cleavability of the vc-seco-DUBA linker-drug, combined with cell permeability of the toxin, gives BYON3521 the intrinsic capacity to kill neighboring MET-negative tumor cells as well, also referred to as bystander activity. Cocultured MET-negative Jurkat NucLight Red and MET-positive tumor cells (1:1 ratio) were treated with BYON3521 and proliferation of Jurkat NucLight Red cells was followed in time. In those cocultures, BYON3521 was able to induce not only cell death in MET-positive cells, but also induced cell killing of the MET-negative Jurkat NucLight Red cells
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[1]
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| yes |
The cleavability of the vc-seco-DUBA linker-drug, combined with cell permeability of the toxin, gives BYON3521 the intrinsic capacity to kill neighboring MET-negative tumor cells as well, also referred to as bystander activity. Cocultured MET-negative Jurkat NucLight Red and MET-positive tumor cells (1:1 ratio) were treated with BYON3521 and proliferation of Jurkat NucLight Red cells was followed in time. In those cocultures, BYON3521 was able to induce not only cell death in MET-positive cells, but also induced cell killing of the MET-negative Jurkat NucLight Red cells.
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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) | 132 | ug/mL |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
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| Maximum Observed Concentration (Cmax) | 4.85 | ug/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.
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| Maximum Observed Concentration (Cmax) | 11.7 | ug/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.
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| Maximum Observed Concentration (Cmax) | 46.5 | ug/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg.
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| Maximum Observed Concentration (Cmax) | 130 | ug/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg.
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| Maximum Observed Concentration (Cmax) | 4.96 | ug/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg.
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| Maximum Observed Concentration (Cmax) | 19 | ug/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.
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| Maximum Observed Concentration (Cmax) | 57.4 | ug/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.
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| Maximum Observed Concentration (Cmax) | 187 | ug/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg.
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| Maximum Observed Concentration (Cmax) | 21.8 | ug/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg.
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[1] |
| Maximum Observed Concentration (Cmax) | 32 | ug/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg.
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| Area Under the Concentration-Time Curve (AUC) | 896 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 2330 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 7500 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 32300 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 355 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 1670 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 5920 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 33900 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4020 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7980 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 1040 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2910 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1700 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUCinf.
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| Area Under the Concentration-Time Curve (AUC) | 6850 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUCinf.
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| Maximum Observed Concentration (Cmax) | 132 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 132 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.
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[1] |
| Maximum Observed Concentration (Cmax) | 169 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 190 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.
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| Maximum Observed Concentration (Cmax) | 371 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 390 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.
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| Maximum Observed Concentration (Cmax) | 676 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 659 | ug/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.
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| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 9760 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 18200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 19600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 43100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 39200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 77300 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 78900 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUClast.
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| Area Under the Concentration-Time Curve (AUC) | 9670 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUCinf.
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| Area Under the Concentration-Time Curve (AUC) | 1070 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUCinf.
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| Area Under the Concentration-Time Curve (AUC) | 18500 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 19800 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 45600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 42100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 89100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUCinf.
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| Area Under the Concentration-Time Curve (AUC) | 88600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUCinf.
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| Maximum Observed Concentration (Cmax) | 115 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 128 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female.
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| Maximum Observed Concentration (Cmax) | 467 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 445 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female.
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[1] |
| Maximum Observed Concentration (Cmax) | 742 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male.
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| Maximum Observed Concentration (Cmax) | 737 | ug/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 9450 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 10300 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 62400 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 53600 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 101000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 116000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female, AUClast.
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[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
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[1] |
| Volume of Distribution (Vd) | 47.9 | mL/kg |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 896 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2330 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7500 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 32300 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 355 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1670 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5920 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 33900 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4020 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 7980 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1040 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2910 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1700 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6850 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUCinf.
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[1] |
| Volume of Distribution (Vd) | 74.5 | mL/h/kg |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.
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[1] |
| Volume of Distribution (Vd) | 108 | mL/h/kg |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.
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[1] |
| Volume of Distribution (Vd) | 73.8 | mL/h/kg |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.
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[1] |
| Volume of Distribution (Vd) | 104 | mL/h/kg |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 9760 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 18200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 19600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 43100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 77300 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 78900 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9670 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1070 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18500 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 19800 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 45600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 42100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 89100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 88600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUCinf.
|
[1] |
| Volume of Distribution (Vd) | 47.9 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.
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[1] |
| Volume of Distribution (Vd) | 47.9 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.
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[1] |
| Volume of Distribution (Vd) | 54 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.
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[1] |
| Volume of Distribution (Vd) | 45.6 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.
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[1] |
| Volume of Distribution (Vd) | 66.2 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.
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[1] |
| Volume of Distribution (Vd) | 60.8 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.
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[1] |
| Volume of Distribution (Vd) | 57.8 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.
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[1] |
| Volume of Distribution (Vd) | 67.1 | mL/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 9450 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male, AUClast.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 10300 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 62400 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 53600 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 101000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 116000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female, AUClast.
|
[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 896 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 2330 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7500 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 32300 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 355 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1670 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5920 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 33900 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4020 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7980 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1040 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 2910 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1700 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 6850 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9760 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 19600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 43100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 77300 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 78900 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9670 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1070 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18500 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 19800 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 45600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 89100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 88600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9450 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 10300 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 62400 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 53600 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 101000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 116000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female, AUClast.
|
[1] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 60.7 | h |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
|
[1] |
| Clearance (CL) | 0.519 | mL/h/kg |
5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.
|
[1] |
| Elimination Half-Life (t1/2) | 181 | h |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.
|
[1] |
| Elimination Half-Life (t1/2) | 221 | h |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.
|
[1] |
| Elimination Half-Life (t1/2) | 87.5 | h |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 896 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 2330 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7500 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 32300 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 355 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1670 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 5920 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 33900 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 4020 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 7980 | ug*h/mL |
Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1040 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 2910 | ug*h/mL |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1700 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 6850 | ug*h/mL |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUCinf.
|
[1] |
| Clearance (CL) | 0.287 | mL/h/kg |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.
|
[1] |
| Clearance (CL) | 0.344 | mL/h/kg |
Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.
|
[1] |
| Clearance (CL) | 0.59 | mL/h/kg |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.
|
[1] |
| Clearance (CL) | 0.438 | mL/h/kg |
Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.
|
[1] |
| Elimination Half-Life (t1/2) | 60.7 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 69.1 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 93.2 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 78 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 143 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 125 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 152 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 172 | h |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9520 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9760 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 19600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 43100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 39200 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 77300 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 78900 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9670 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 1070 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 18500 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 19800 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 45600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 42100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 89100 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUCinf.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 88600 | ug*h/mL |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUCinf.
|
[1] |
| Clearance (CL) | 0.519 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.
|
[1] |
| Clearance (CL) | 0.467 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.
|
[1] |
| Clearance (CL) | 0.378 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.
|
[1] |
| Clearance (CL) | 0.354 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.
|
[1] |
| Clearance (CL) | 0.342 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.
|
[1] |
| Clearance (CL) | 0.357 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.
|
[1] |
| Clearance (CL) | 0.304 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.
|
[1] |
| Clearance (CL) | 0.295 | mL/h/kg |
Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 74.7 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 74.4 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 172 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 170 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female.
|
[1] |
| Elimination Half-Life (t1/2) | 134 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male.
|
[1] |
| Elimination Half-Life (t1/2) | 237 | h |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 9450 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 10300 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 62400 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 53600 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 101000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male, AUClast.
|
[1] |
| Area Under the Concentration-Time Curve (AUC) | 116000 | ug*h/mL |
Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female, AUClast.
|
[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 |
Eligible patients must have advanced/metastatic c-MET-positive tumors (confirmed by IHC/dISH/mutation) refractory to standard therapy, ECOG ≤1, and adequate organ function. Key exclusions include prior SYD985 treatment, recent anticancer therapy (<4 weeks), active pneumonitis/cardiovascular disease, or untreated/symptomatic brain metastases. Keratitis and glomerulonephritis history also preclude participation.
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|
||||
| Administration Dosage |
BYON3521 (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05323045 | Clinical Status | PHASE1 | ||
| Clinical Description | A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours | ||||
| Primary Endpoint |
The study evaluates safety in Part 1 (dose-escalation) by monitoring dose-limiting toxicities (DLTs) during the first 21-day cycle to determine the maximum tolerated dose (MTD).
|
||||
| Other Endpoint |
Efficacy in Part 2 (expansion cohorts) is assessed via objective response rate (ORR) at 21-day intervals across four tumor types: non-squamous NSCLC (Cohort A), gynecological cancers (B), pancreatic adenocarcinoma (C), and uveal melanoma (D), all requiring c-MET overexpression (IHC ≥2+).
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Patients with previously treated progressive locally advanced or metastatic solid tumors, MET positive.
|
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| Administration Dosage |
.
|
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| Related Clinical Trial | |||||
| NCT Number | NCT05323045 | Clinical Status | Phase 1 | ||
| Clinical Description | A first-in-human dose-escalation and expansion trial with the antibody-drug conjugate BYON3521 to evaluate the safety, pharmacokinetics and efficacy in patients with c-met expressing locally advanced or metastatic solid tumours. | ||||
References