TRIAL DETAIL

A Study of HQP1351 in Patients With GIST or Other Solid Tumors

Drug:
Trial Name:
A Study of HQP1351 in Patients With GIST or Other Solid Tumors
NCT#:
Conditions:
Solid Tumors
Status:
Recruiting
Phase:
1
Start Date 07/11/2018
Age of Trial (yrs) 5.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
SJ-0003
Sponsor:
Ascentage Pharma Group Inc.
Patient Contact:
Yifan Zhai, M.D., Ph.D. +86-20-28069260 yzhai@ascentagepharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Detailed Description:
The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.

Criteria

Inclusion Criteria:

Male or not pregnant or lactating women, ageā‰„12years.
Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).

Trial Links

Trial Results

 

Drug Information

Preclinical development of HQP1351, a multikinase inhibitor targeting a broad spectrum of mutant KIT kinases, for the treatment of imatinib-resistant gastrointestinal stromal tumors.
 

Trial Sites

Name
Address
City
State
Zip
Country
Guangzhou
Guandong
510000
China
Guangzhou
Guangdong
China
Wuhan
Hubei
215316
China
Beijing
China
Shanghai
China
Zhengzhou
Henan
China