Spots Global Cancer Trial Database for Dose Escalation and Expansion Study of SYH2043 in Patients With Advanced Malignant Tumors

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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