Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ZUQNL
ADC Name
BAT-8001
Synonyms
BAT 8001; Anti-ErbB2 antibody drug conjugate; Anti-HER2 antibody drug conjugate; BAT8001
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Organization
Bio-Thera Solutions, Ltd.
Drug Status
Phase 1/2
Indication
In total 2 Indication(s)
Metastatic breast cancer [ICD11:2C6Y]
Phase 2
HER2(+) solid tumors [ICD11:2A00-2A0Z|2B50-2F9Z]
Terminated in phase 2
Antibody Name
BAT0606
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
  Antigen Info 
Payload Name
Maytansinoid derivative
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
6-Maleimidocaproic acid
  Linker Info 
Conjugate Type
Random conjugation through nucleophilic lysines.
Combination Type
Batansine
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT04189211
Phase 1
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.
Undisclosed  NCT04185649
Phase 3
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.

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Undisclosed  NCT04151329
Phase 1/2
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.

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Undisclosed  NCT04189211
Phase 1
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.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
41.40%
Patients Enrolled
HER2-positive locally advanced or metastatic breast cancer.
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.
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.
Experiment 2 Reporting the Activity Date of This ADC [2]
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 3 Reporting the Activity Date of This ADC [3]
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 4 Reporting the Activity Date of This ADC [4]
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
Ref 1 Safety, tolerability, and pharmacokinetics of BAT8001 in patients with HER2-positive breast cancer: An open-label, dose-escalation, phase I study. Cancer Commun (Lond). 2021 Feb;41(2):171-182.
Ref 2 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, NCT04185649
Ref 3 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, NCT04151329
Ref 4 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, NCT04189211

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