TRIAL DETAIL

A Study of NB003 in Patients With Advanced Malignancies

Drug:
Trial Name:
A Study of NB003 in Patients With Advanced Malignancies
NCT#:
Conditions:
Solid Tumors
Status:
Recruiting
Phase:
1
Start Date 07/06/2021
Age of Trial (yrs) 1.9
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Inhibit KIT and PDGFRa
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
NB003-01
Sponsor:
Ningbo Newbay Technology Development Co., Ltd
Patient Contact:
Yan Wang +8615388232733 TMF-ISF@newbaypharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Detailed Description:

This is a phase 1, open-label, multicenter study of NB003 administered orally in patients with advanced GIST who have progressed on or had an intolerability to imatinib and other standard of care (SoCs) or refused other SoCs, and patients with an advanced malignancy other than Gastrointestinal stromal tumor (GIST)that harbors KIT(CD117) or platelet derived growth factor receptor（PDGFRa) gene alteration who have relapsed or have refractory disease without an available effective therapy.

The study is comprised of a dose escalation phase to determine the MTD and the RP2D and an expansion phase to further explore the safety and efficacy of NB003.

Trial Links

Trial Results

Drug Information
Discovery and pharmacological characterization of AZD3229, a potent KIT/PDGFRα inhibitor for treatment of gastrointestinal stromal tumors
 
The Pharmacokinetic-Pharmacodynamic (PKPD) Relationships of AZD3229, a Novel and Selective Inhibitor of KIT, in a Range of Mouse Xenograft Models of GIST
 
Discovery of N-(4-{[5-Fluoro-7-(2-methoxyethoxy)quinazolin-4-yl]amino}phenyl)-2-[4-(propan-2-yl)-1H-1,2,3-triazol-1-yl]acetamide (AZD3229), a Potent Pan-KIT Mutant Inhibitor for the Treatment of Gastrointestinal Stromal Tumors
 

Trial Sites

Name
Address
City
State
Zip
Country
1275 York Ave
New York
NY
10065
USA
Beijing
100142
China
Shanghai
China