Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0SHGPV
ADC Name
PF-06647263
Synonyms
Anti-EFNA4-ADC; Anti-EFNA4-monoclonal-antibody-calicheamicin-conjugate; PF 6647263; PF06647263
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Organization
Pfizer Inc.
Drug Status
Terminated in phase 1
Indication
In total 1 Indication(s)
Triple negative breast cancer [ICD11:2C60-2C65]
Terminated in phase 1
Drug-to-Antibody Ratio
4.6
Structure
Antibody Name
Anti-EFNA4 mAb huE22
  Antibody Info 
Antigen Name
Ephrin-A4 (EFNA4)
  Antigen Info 
Payload Name
N-acetyl-gamma-calicheamicin
  Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
AcButDMH
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Ozogamicin
TTD ID
D0W7NL
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
Objective Response Rate (ORR)  NCT02078752
Phase 1
A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
Undisclosed  NCT02078752
Phase 1
A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
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 Objective Response Rate (ORR)
10.40% (all dose-escalation groups)
9.10% (in the 0.015 mg/kg QW group )
Patients Enrolled
Advanced solid tumors resistant to standard therapy or for which no standard therapy.
Administration Dosage
Every 3 weeks (Q3W) or every week (QW), following a modified toxicity probability interval (mTPI) method (initial dosing: 0.015 mg/kg Q3W).
Related Clinical Trial
NCT Number NCT02078752  Clinical Status Phase 1
Clinical Description A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
Primary Endpoint
Six (10.00%) patients achieved a confirmed partial response and 22 (36.70%) patients had stable disease. No correlations were observed between tumor responses and EFNA4 expression levels. Study findings showed manageable safety and favorable PK for PF-06647263 administered QW at the RP2D,with preliminary evidence of limited antitumor activity in patients with TNBC and ovarian cancer.

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Other Endpoint
The RP2D was determined to be 0.015 mg/kg QW.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT02078752  Clinical Status Phase 1
Clinical Description A first-in-human phase 1, dose escalation, safety and pharmacokinetic study of PF-06647263 in adult patients with advanced solid tumors.
References
Ref 1 First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors. Int J Cancer. 2019 Oct 1;145(7):1798-1808.
Ref 2 A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647263 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

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