Spots Global Cancer Trial Database for A Study of SKLB1028 in Patients With Advanced Solid Tumor

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Trial Identification

Brief Title: A Study of SKLB1028 in Patients With Advanced Solid Tumor

Official Title: An Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SKLB1028 in Patients With Advanced Solid Tumors

Study ID: NCT05072522

Conditions

Advanced Solid Tumors

Interventions

SKLB1028

Study Description

Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.

Detailed Description: This study is divided into two stages. The first stage is the dose-escalation stage to evaluate the safety, tolerance and pharmacokinetics of SKLB1028 in patients with advanced solid tumors. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD). Patients with advanced solid tumors will receive SKLB1028 orally once daily (QD) in continuous 28-day cycles, starting at a dose of 200 mg and rising to 400 mg. The second stage is cohort-expansion study. The safe tolerated dose group will be selected for case expansion. At this stage, patients with advanced solid tumors with better response on SKLB1028 are mainly enrolled.