NCT06117540

A Study of WX390 in Patients With Advanced Solid Tumors

An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: * PFS, OS, DoR at week 48; * antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.

Detailed description

This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	WX390	WX390 tablet, 1.1 mg once a day

Timeline

• Start date: 2021-05-11
• Primary completion: 2025-06-12
• Completion: 2026-06-12
• First posted: 2023-11-07
• Last updated: 2024-11-19

Locations

1 site across 1 country: China