NCT05609019

A Study Evaluating SYHX2005 in the Treatment of Patients With Advanced Solid Tumors

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SYHX2005 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SYHX2005	Tablets. Take orally.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-11-08
• Last updated: 2022-11-08