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; PF-06647263; PF06647263; PF-0667263; PF 0667263; PF0667263
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Organization
Pfizer Inc.
Drug Status
Phase 1 (Terminated)
Indication
In total 2 Indication(s)
Breast cancer
Phase 1
Clinical Trial
Solid tumor
Phase 1
Clinical Trial
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 Lysines
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