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Clinical Trial Summary

The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SYH2043 in patients with advanced malignant tumors.


Clinical Trial Description

This study is an open-label, single-arm, multi-center Phase I clinical study, which includes four stages: A: Dose-escalation Stage: The dose escalation stage is divided into 5 dose levels, and a Bayesian Optimal Interval Design (BOIN) including accelerated titration will be used for dose escalation. B: PK Expansion Stage: Two or three dose groups will be selected for PK expansion; After PK extension the cohort extension study will be conducted as required, and will include 4 cohorts according to the tumor types. C: Combination dose Escalation: This study will use a 3+3 design with up to 2 dose escalation cohorts at increasing levels. D: According to the results of stage C, 1-2 combination doses will be selected for combination dose expansion, and Simon 2 stage was adopted for the expansion stage. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05728541
Study type Interventional
Source CSPC Ouyi Pharmaceutical Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date March 1, 2023
Completion date March 1, 2026

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