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.
Description: Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.Measure: Safety and tolerance Time: 30 days after the last dose of HQP1351
Description: Pharmacokinetic evaluationMeasure: Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1. Time: 28 days
Description: Pharmacokinetic evaluationMeasure: Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1. Time: 28 days
Description: Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1Measure: Anti-tumor activities of HQP1351 Time: 3-6 months
There is one SNP
Among them, GIST patients are required primary imatinib resistance (PDGFRA D842V mutation or NF1 mutation) or failed to previous treatment with imatinib or imatinib and at least one other TKI. 3. ECOG≤ 2. 4. Estimated survival at least 3 months. --- D842V ---