Health Trials

About this trial

This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.

Eligibility criteria

Qualifiers

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).

ECOG≤ 2.

Estimated survival at least 3 months.

Disqualifiers

Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.

Received any TKIs within 14 days before first dose of HQP1351.

Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.

Have not recovered (> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.

Trial design

Treatments tested in this trial

  • HQP1351

Treatment groups

100 Participants
are divided into 4 treatment groups

Locations

6
Guangdong general hospital GuangzhouGuangdong, China
Sun-Yat Sen University Cancer Center510060, GuangzhouGuangdong, China
Henan cancer hospital ZhengzhouHenan, China
Union Hospital Tongji Medical College of Huazhong University of Science ang Technology215316, WuhanHubei, China

Sponsors and collaborators

Ascentage Pharma Group Inc.

Lead sponsor

HealthQuest Pharma Inc.

Collaborator

Source ClinicalTrials.gov