A Study Evaluating SYHX2005 in the Treatment of Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
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.