Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ZUQNL
ADC Name
BAT8001
Synonyms
Anti-ErbB2 antibody drug conjugate; Anti-HER2 antibody drug conjugate; BAT 8001; BAT-8001; BAT8001
   Click to Show/Hide
Organization
Bio-Thera Solutions, Ltd.
Drug Status
Phase 3 (Terminated)
Indication
In total 2 Indication(s)
Breast cancer
Phase 3
Clinical Trial
Gastric cancer
Phase 1
Clinical Trial
Drug-to-Antibody Ratio
3.5
Structure
Antibody Name
BAT0606
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (HER2)
  Antigen Info 
Payload Name
Maytansinoid derivative of batansine
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
6-Maleimidocaproic acid
  Linker Info 
Conjugate Type
Random 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.

   Click to Show/Hide
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.

   Click to Show/Hide
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