NCT05728541

Dose Escalation and Expansion Study of SYH2043 in Patients With Advanced Malignant Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYH2043 in Patients With Advanced Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 367 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	SYH2043	Patients will receive SYH2043 once everyday on day 1-21 of each 28-day cycle

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2023-02-15
• Last updated: 2023-02-17

Locations

1 site across 1 country: China