Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0ZUQNL
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| ADC Name |
BAT8001
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| Synonyms |
BAT8001
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| Organization |
Bio-Thera Solutions (Originator)
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| Drug Status |
Phase 3 (discontinued)
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| Drug-to-Antibody Ratio |
3.5
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| Structure |
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| Antibody Name |
BAT0606
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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 |
Batansine
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Maleimido-caproyl
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
batansine
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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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastric cancer |
2 Trials
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| Breast cancer |
2 Trials
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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 |
|---|---|---|---|---|
| Time to Maximum Concentration (Tmax) | 0.00±0.00 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3).
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[1] |
| Time to Maximum Concentration (Tmax) | 0.00±0.00 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3).
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[1] |
| Time to Maximum Concentration (Tmax) | 0.40±1.26 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10).
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[1] |
| Time to Maximum Concentration (Tmax) | 0.57±1.51 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7).
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[1] |
| Time to Maximum Concentration (Tmax) | 0.00±0.00 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6).
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[1] |
| Maximum Observed Concentration (Cmax) | 27228.77±5960.36 | ng/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3).
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[1] |
| Maximum Observed Concentration (Cmax) | 38469.27±11371.55 | ng/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3).
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[1] |
| Maximum Observed Concentration (Cmax) | 80735.83±24625.42 | ng/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10).
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[1] |
| Maximum Observed Concentration (Cmax) | 92880.49±16660.59 | ng/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7).
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[1] |
| Maximum Observed Concentration (Cmax) | 140088.07±15216.88 | ng/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6).
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1150280.04±426707.90 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2376641.68±824625.87 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3802921.30±1692136.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5052300.32±860926.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6284782.56±1018649.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1155573.32±426217.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2410407.26±803079.58 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3826911.91±1715857.82 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5076495.13±862955.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6320177.65±1034866.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUCinf.
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[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 1150280.04±426707.90 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2376641.68±824625.87 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3802921.30±1692136.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5052300.32±860926.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6284782.56±1018649.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1155573.32±426217.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2410407.26±803079.58 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3826911.91±1715857.82 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5076495.13±862955.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6320177.65±1034866.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUCinf.
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| Volume of Distribution (Vd) | 55.06±14.46 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), Vz, volume of distribution at end phase.
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| Volume of Distribution (Vd) | 106.20±46.76 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), Vz, volume of distribution at end phase.
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[1] |
| Volume of Distribution (Vd) | 84.92±30.81 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), Vz, volume of distribution at end phase.
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[1] |
| Volume of Distribution (Vd) | 109.70±13.88 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), Vz, volume of distribution at end phase.
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[1] |
| Volume of Distribution (Vd) | 99.40±31.47 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), Vz, volume of distribution at end phase.
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[1] |
| Volume of Distribution (Vd) | 55.47±12.13 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), Vss, steady-state volume of distribution.
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[1] |
| Volume of Distribution (Vd) | 89.10±53.68 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), Vss, steady-state volume of distribution.
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[1] |
| Volume of Distribution (Vd) | 56.20±12.68 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), Vss, steady-state volume of distribution.
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[1] |
| Volume of Distribution (Vd) | 58.10±12.15 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), Vss, steady-state volume of distribution.
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[1] |
| Volume of Distribution (Vd) | 53.69±4.47 | mL/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), Vss, steady-state volume of distribution.
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[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 1150280.04±426707.90 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2376641.68±824625.87 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3802921.30±1692136.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5052300.32±860926.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6284782.56±1018649.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1155573.32±426217.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2410407.26±803079.58 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3826911.91±1715857.82 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5076495.13±862955.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6320177.65±1034866.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUCinf.
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[1] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 34.40±5.86 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3).
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[1] |
| Elimination Half-Life (t1/2) | 66.74±2.77 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3).
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[1] |
| Elimination Half-Life (t1/2) | 59.38±30.46 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10).
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[1] |
| Elimination Half-Life (t1/2) | 76.61±6.52 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7).
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[1] |
| Elimination Half-Life (t1/2) | 70.59±20.49 | h |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6).
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1150280.04±426707.90 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2376641.68±824625.87 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3802921.30±1692136.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5052300.32±860926.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6284782.56±1018649.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 1155573.32±426217.67 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 2410407.26±803079.58 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 3826911.91±1715857.82 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 5076495.13±862955.42 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7), AUCinf.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 6320177.65±1034866.74 | ng*h/mL |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6), AUCinf.
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| Clearance (CL) | 1.17±0.53 | mL/h/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 1 (1.2 mg/kg; n = 3).
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[1] |
| Clearance (CL) | 1.10±0.45 | mL/h/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 2 (2.4 mg/kg; n = 3).
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[1] |
| Clearance (CL) | 1.28±1.01 | mL/h/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 3 (3.6 mg/kg; n = 10).
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[1] |
| Clearance (CL) | 0.97±0.18 | mL/h/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 4 (4.8 mg/kg; n = 7).
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[1] |
| Clearance (CL) | 0.98±0.18 | mL/h/kg |
Pharmacokinetic parameters of BAT8001 in cycle 1, Cohort 5 (6.0 mg/kg; n = 6).
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[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 | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
41.40%
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| Patients Enrolled |
Eligible patients must have HER2-positive (IHC 3+/ISH+) advanced breast/gastric cancer unamenable to standard therapy, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and anthracycline exposure below doxorubicin-equivalent 360mg/m2. Exclusions cover active HBV/HCV/HIV, uncontrolled infections, severe cardiopulmonary diseases (NYHA ≥2, CHF, recent MI), symptomatic CNS metastases, or Grade ≥2 neuropathy.
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| Administration Dosage |
This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer (having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1) using a 3 + 3 design of escalating BAT8001 doses. Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.2, 2.4, 3.6, 4.8, and 6.0 mg/kg. The primary objective was to evaluate the safety and tolerability of BAT8001. Preliminary activity of BAT8001 was also assessed as a secondary objective.
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| Related Clinical Trial | |||||
| NCT Number | NCT04189211 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients With HER2-Positive Solid Tumors | ||||
| Primary Endpoint |
Primary safety endpoints include dose-limiting toxicity (DLT) criteria spanning hematologic, hepatic, cardiac (e.g., LVEF ≤45% with ≥10% decrease) and other organ toxicities (Grade ≥3) assessed over 21 days post-dose. Pharmacokinetic parameters (AUC, Cmax, t1/2) of BAT8001, total antibody, and batansine are evaluated during Cycles 1-4 (21-day cycles), alongside immunogenicity monitoring (ADA/NADA). Maximum tolerated dose (MTD) is determined when ≤1/6 patients experience DLT.
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| Other Endpoint |
Efficacy measures comprise progression-free survival (PFS) and overall response rate (ORR) per RECIST v1.1, tracked from baseline until study conclusion (up to 3 years).
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
82.80%
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| Patients Enrolled |
Eligible patients must have HER2-positive (IHC 3+/ISH+) advanced breast/gastric cancer unamenable to standard therapy, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and anthracycline exposure below doxorubicin-equivalent 360mg/m2. Exclusions cover active HBV/HCV/HIV, uncontrolled infections, severe cardiopulmonary diseases (NYHA ≥2, CHF, recent MI), symptomatic CNS metastases, or Grade ≥2 neuropathy.
Click to Show/Hide
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| Administration Dosage |
This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer (having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1) using a 3 + 3 design of escalating BAT8001 doses. Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.2, 2.4, 3.6, 4.8, and 6.0 mg/kg. The primary objective was to evaluate the safety and tolerability of BAT8001. Preliminary activity of BAT8001 was also assessed as a secondary objective.
Click to Show/Hide
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| Related Clinical Trial | |||||
| NCT Number | NCT04189211 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients With HER2-Positive Solid Tumors | ||||
| Primary Endpoint |
Primary safety endpoints include dose-limiting toxicity (DLT) criteria spanning hematologic, hepatic, cardiac (e.g., LVEF ≤45% with ≥10% decrease) and other organ toxicities (Grade ≥3) assessed over 21 days post-dose. Pharmacokinetic parameters (AUC, Cmax, t1/2) of BAT8001, total antibody, and batansine are evaluated during Cycles 1-4 (21-day cycles), alongside immunogenicity monitoring (ADA/NADA). Maximum tolerated dose (MTD) is determined when ≤1/6 patients experience DLT.
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| Other Endpoint |
Efficacy measures comprise progression-free survival (PFS) and overall response rate (ORR) per RECIST v1.1, tracked from baseline until study conclusion (up to 3 years).
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Inclusion criteria require HER2-positive breast cancer (IHC 3+/FISH+), prior taxane/trastuzumab therapy, measurable lesions (RECIST 1.1), ECOG 0-1, LVEF ≥50%, and contraception for participants of childbearing potential. Exclusion criteria include grade ≥2 neuropathy, active brain metastases, unresolved radiation toxicity, severe cardio-pulmonary diseases, recent myocardial infarction, uncontrolled systemic illness, malabsorption disorders, or intolerance to trastuzumab.
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| Administration Dosage |
3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT04185649 | Clinical Status | PHASE3 | ||
| Clinical Description | A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China | ||||
| Primary Endpoint |
The primary endpoint is progression-free survival (PFS), defined as time from randomization to disease progression (RECIST v1.1) or death, assessed up to 18 months.
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| Other Endpoint |
Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), clinical benefit rate (CBR), serum concentrations of BAT8001 and its total antibody, plasma concentration of batansine, and percentage of participants with anti-therapeutic antibodies (ATA), all measured up to 30 months.
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| Experiment 4 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-75 years) must have HER2-positive advanced solid tumors (IHC 3+/ISH+) with ECOG 0-1, measurable lesions (RECIST 1.1), and adequate organ function. Exclusions include recent anti-tumor therapy (≤4 weeks), uncontrolled CNS metastases, active autoimmune diseases, severe cardiovascular conditions, or prior anthracycline overdose (doxorubicin >360mg/m2 equivalent).
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| Administration Dosage |
Experimental: 2.4mg/kg of BAT8001 Drug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box, 2.4mg/kg IV infusions Experimental: 3.6mg/kg of BAT8001 Drug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box,3.6mg/kg IV infusions
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| Related Clinical Trial | |||||
| NCT Number | NCT04151329 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Evaluation for the Safety of BAT1306 and BAT8001 Injection for the Treatment of Patients With HER2-positive Advanced Solid Tumors Phase I/IIa Clinical Trials of Sexual, Tolerability and Pharmacokinetic Characteristics | ||||
| Primary Endpoint |
Primary endpoints include dose-limiting toxicity (DLT) for safety assessment over 3 weeks, along with pharmacokinetic parameters (AUC, Cmax, t1/2). Immunogenicity measures (ADA and NADA) are evaluated throughout the study period (avg. 6-12 months).
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| Other Endpoint |
Efficacy assessments consist of ORR, PFS, DCR, and DOR as secondary endpoints, monitored through study completion (avg. 6-12 months).
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| Experiment 5 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
41.40%
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| Patients Enrolled |
HER2-positive locally advanced or metastatic breast cancer.
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| Administration Dosage |
Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.20, 2.40, 3.60, 4.80, and 6.00 mg/kg.
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| Related Clinical Trial | |||||
| NCT Number | NCT04189211 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, dose escalation phase 1 clinical trial on safety, tolerability and pharmacokinetics of BAT8001 for injection in patients with HER2-positive solid tumors. | ||||
| Primary Endpoint |
For BAT8001, 3.60 mg/kg was determined to be the MTD.
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| Experiment 6 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04185649 | Clinical Status | Phase 3 | ||
| Clinical Description | A clinical study evaluating the efficacy and safety of BAT8001 injection for the treatment of HER2-positive advanced breast cancer - a multicenter, randomized, open-label, positive-controlled, superiority phase 3 clinical trial in china. | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [6] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04151329 | Clinical Status | Phase 1/2 | ||
| Clinical Description | Evaluation for the safety of BAT1306 and BAT8001 injection for the treatment of patients with HER2-positive advanced solid tumors phase 1/2a clinical trials of sexual, tolerability and pharmacokinetic characteristics. | ||||
| Experiment 8 Reporting the Activity Date of This ADC | [7] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04189211 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, dose escalation phase 1 clinical trial on safety, tolerability and pharmacokinetics of BAT8001 for injection in patients with HER2-positive solid tumors. | ||||
References