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

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

Solid Tumors

Recruiting

1

Start Date 07/11/2018

Age of Trial (yrs) 5.2

Gleevec-resistant

KIT inhibitor

Block KIT

Specifically GIST plus other cancers

SJ-0003

Ascentage Pharma Group Inc.

Yifan Zhai, M.D., Ph.D. +86-20-28069260 yzhai@ascentagepharma.com

Oral

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, age≥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).