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.
Name: HQP1351
Description: HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.Type: DrugHQP1351 30mg HQP1351 40mg HQP1351 50mg
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 HQP1351Description: Pharmacokinetic evaluation
Measure: Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1. Time: 28 daysDescription: Pharmacokinetic evaluation
Measure: 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 daysDescription: Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1
Measure: Anti-tumor activities of HQP1351 Time: 3-6 monthsAllocation: Randomized
Parallel Assignment
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 ---