Spots Global Cancer Trial Database for A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

Official Title: A Phase I, Open-label, Multicenter, Dose-escalation and Dose-expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of WM-S1-030 in Patients With Advanced Solid Tumors

Study ID: NCT04801095

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Interventions

WM-S1-030

Study Description

Brief Summary: This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.

Detailed Description: This is a Phase I, open-label, multicenter, dose-escalation, and dose-expansion study of WM-S1-030 in patients with advanced or metastatic solid tumors. The study will be conducted in 2 parts; a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). Part 1 will investigate oral administration of WM-S1-030 as monotherapy. Once the MTD or recommended dose is identified in Part 1, additional patients will be enrolled into Part 2 to further investigate efficacy, safety, PK, pharmacodynamics, dosing interval or schedule, and food effect on the single-dose PK of WM-S1-030.