A Study of HQP1351 in Patients With GIST or Other Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorAscentage Pharma Group Inc.
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 groupsSponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
HealthQuest Pharma Inc.
Collaborator
Source ClinicalTrials.gov