Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0WRFYU
ADC Name
PF-06650808
Synonyms
PF-6650808; PF 6650808
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Organization
Pfizer Inc.
Drug Status
Terminated in phase 1
Indication
In total 1 Indication(s)
Breast cancer [ICD11:2C60-2C65]
Terminated in phase 1
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 conjugation through reduced inter-chain cysteines.
Combination Type
Vc0101
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

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