Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0BFNMH
ADC Name
GQ-1001
Synonyms
GQ1001; GQ 1001
   Click to Show/Hide
Organization
GeneQuantum Healthcare (Suzhou) Co. Ltd.
Drug Status
Phase 2
Indication
In total 2 Indication(s)
Breast cancer [ICD11:2C60-2C65]
Phase 2
Gastric cancer [ICD11:2B72]
Phase 1
Drug-to-Antibody Ratio
2
Structure
Antibody Name
Trastuzumab
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
  Antigen Info 
Payload Name
Mertansine DM1
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
MCC-Gly6-Thr-Glu3-Pro-Leu-Ala3-Leu
  Linker Info 
Conjugate Type
Site-specific conjugation through the Sortase A.
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Partial Response (PR)  NCT04450732
Phase 1
A phase 1, first-in-human, multicenter, open-label, study of GQ1001, a HER2 targeted antibody-drug conjugate, administered intravenously, in adult patients with HER2-positive advanced solid tumors.
Undisclosed  NCT05575804
Phase 1/2
Phase 1b/2 study of GQ1001 and pyrotinib in HER2 positive metastatic breast cancer patients who had failed previous anti-HER2 treatment GRACE.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Partial Response (PR)
40.00%
Patients Enrolled
HER2-positive advanced solid tumors.
Administration Dosage
Administered intravenously as a monotherapy on Day 1 of 21-day cycles. The starting dose was 1.20 mg/kg, followed by 2.40, 3.60, 4.80, 6.00, 7.20 and 8.40 mg/kg.
Related Clinical Trial
NCT Number NCT04450732  Clinical Status Phase 1
Clinical Description A phase 1, first-in-human, multicenter, open-label, study of GQ1001, a HER2 targeted antibody-drug conjugate, administered intravenously, in adult patients with HER2-positive advanced solid tumors.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05575804  Clinical Status Phase 1/2
Clinical Description Phase 1b/2 study of GQ1001 and pyrotinib in HER2 positive metastatic breast cancer patients who had failed previous anti-HER2 treatment GRACE.
References
Ref 1 GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study. Cancer Res (2023) 83 (8_Supplement): CT178.
Ref 2 Phase Ib/II Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 TreatmentGRACE, NCT05575804

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