Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 1:55 PM
Study NCT ID:
NCT06132932
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Organization:
Study Overview
Official Title:
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390, a PI3K/mTOR Dual Inhibitor, for the Treatment of Advanced Solid Tumors With PIK3CA Mutations
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 in patients with advanced solid tumors. The main question it aims to answer is:
• safety and preliminary efficacy in WX390 therapy. Participants will be treated with WX390 orally and follow the efficacy and safety evaluation according to the protocol.
• safety and preliminary efficacy in WX390 therapy. Participants will be treated with WX390 orally and follow the efficacy and safety evaluation according to the protocol.
Detailed Description:
This study is a multicenter, open-label phase Ib/IIa clinical trial for patients with advanced solid tumors who have failed standard treatment. The study adopts a basket design, divided into 6 cohorts, with a total of 70-80 advanced solid tumor patients with PIK3CA mutations enrolled. Participants will receive WX390 treatment administered continuously daily, with each cycle lasting 28 days, until disease progression or intolerable toxicity occurs. During the study, safety and efficacy will be evaluated, with efficacy assessment based on RECIST 1.1. In addition, the study will collect tumor tissue or blood samples from the participants to explore the relationship between other biomarkers and treatment efficacy, as well as the impact of changes in PIK3CA mutation status before and after treatment on efficacy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: