This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Tablets. Take orally.
Maximum Tolerated Dose(MTD)
Maximum tolerated dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR) in stage 2
Overall Response Rate
Time frame: up to approximately 2 years
Occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Rate of adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
Overall Response Rate (ORR) in stage 1
Overall Response Rate
Time frame: 12 months
Duration of Response (DOR)
Duration of Response
Time frame: 12 months
Disease Control Rate (DCR)
Disease Control Rate
Time frame: 12 months
Progression-Free Survival (PFS)
Progression-free survival
Time frame: 12 months
Overall Survival (OS)
Overall Survival
Time frame: 12 months
Pharmacokinetic profile,e.g.AUC of SYHX2005
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: 12 months
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