NCT04801095

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wellmarker Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Colorectal Cancer
• Lung Cancer
• Pancreatic Cancer
• Cholangiocarcinoma
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	WM-S1-030	WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.

Timeline

• Start date: 2021-07-14
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2021-03-16
• Last updated: 2022-09-16

Locations

6 sites across 2 countries: Australia, South Korea