Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0WRFYU
ADC Name
PF-06650808
Synonyms
PF 6650808; PF-06650808; PF-6650808
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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
Structure
Antibody Name
Anti-NOTCH3 mAb hu28
  Antibody Info 
Antigen Name
Neurogenic locus notch homolog protein 3 (NOTCH3)
  Antigen Info 
Payload Name
Auristatin 0101
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random Cysteines
Combination Type
pelidotin
TTD ID
D00OVE
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)  NCT02129205
Phase 1
A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 In patients with advanced solid tumors.
Undisclosed  NCT02129205
Phase 1
A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 in 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)
9.68% (all response-evaluable patients)
16.67% (patients with breast cancer)
21.43% (patients with ER+ breast cancer)
Patients Enrolled
Locally advanced/metastatic solid tumors resistant to standard therapy or with no available standard therapy; Eastern Cooperative Oncology Group (ECOG) performance score (PS) 01; a life expectancy 12 weeks; and adequate bone marrow, hepatic, and renal function.
Administration Dosage
Intravenously every 3 weeks (Q3W) starting at a dose of 0.20 mg/kg to be escalated up to 6.40 mg/kg, following the modified continual reassessment method (mCRM).
Related Clinical Trial
NCT Number NCT02129205  Clinical Status Phase 1
Clinical Description A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 In patients with advanced solid tumors.
Primary Endpoint
OrR=9.68% for all response-evaluable patients (N=3/31), ORR=16.67% for patients with breast cancer (N=3/18), ORR=21.43% for patients with ER+ breast cancer (N=3/14). Five patients with advanced BC achieved PR as best overall response (BOR): 2 at 2.0 mg/kg, 1 at 2.4 mg/kg, and 2 at 3.6 mg/kg.
Other Endpoint
The maximum tolerated dose (MTD) was estimated to be 2.40 mg/kg.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT02129205  Clinical Status Phase 1
Clinical Description A phase 1 dose escalation study evaluating the safety and tolerability of PF-06650808 in patients with advanced solid tumors.
References
Ref 1 A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130.
Ref 2 A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS